{"id":87559,"date":"2026-08-07T12:53:45","date_gmt":"2026-08-07T19:53:45","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=library&#038;p=87559"},"modified":"2026-08-07T12:53:45","modified_gmt":"2026-08-07T19:53:45","slug":"requirements-management-guide-medical-devices-essential-performance-requirements","status":"publish","type":"library","link":"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/essential-performance-requirements\/","title":{"rendered":"Essential Performance Requirements and How to Identify Them"},"content":{"rendered":"<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt25zx8k-95cea1c5329117157a2b681b40296fe4\">\n.avia-section.av-kt25zx8k-95cea1c5329117157a2b681b40296fe4{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-header.png);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:0px;\nmargin-bottom:0px;\n}\n<\/style>\n<div id='requirements-management-header'  class='avia-section av-kt25zx8k-95cea1c5329117157a2b681b40296fe4 main_color avia-section-default avia-no-border-styling av-small-hide av-mini-hide avia-full-stretch avia-bg-style-scroll container_wrap sidebar_right'  data-section-bg-repeat='stretch'><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-87559'><div class='entry-content-wrapper clearfix'>\r\n<div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-individual'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt265h6u-d6a96dee24290389522c001709d22a48\">\n.flex_column.av-kt265h6u-d6a96dee24290389522c001709d22a48{\norder:0;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-kt265h6u-d6a96dee24290389522c001709d22a48 av_one_third first no_margin flex_column_div av-zero-column-padding avia-link-column av-column-link  '    data-link-column-url=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/\"   ><a class=\"av-screen-reader-only\" href=https:\/\/www.jamasoftware.com\/requirements-management-guide\/ >Follow a manual added link<\/a><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt261529-f74fbfeb09298a4be27cfcf51fc31861\">\n.avia-image-container.av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 av-styling- avia-align-right  right'  ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-56114 avia-img-lazy-loading-not-56114 avia_image ' src=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-150x150.png\" alt='' title='requirements management guide icon'  height=\"150\" width=\"150\" srcset=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-150x150.png 150w, https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-80x80.png 80w, https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon.png 272w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 --><div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-individual'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt2699f2-ecc685273939b22531502fbf4c623f6b\">\n.flex_column.av-kt2699f2-ecc685273939b22531502fbf4c623f6b{\norder:0;\npadding:0px 5% 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-kt2699f2-ecc685273939b22531502fbf4c623f6b av_one_half no_margin flex_column_div avia-link-column av-column-link  '    data-link-column-url=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/\"   ><a class=\"av-screen-reader-only\" href=https:\/\/www.jamasoftware.com\/requirements-management-guide\/ >Follow a manual added link<\/a><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a\">\n#top .av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a av-special-heading-h1 custom-color-heading blockquote modern-quote  left'><h1 class='av-special-heading-tag '  ><em>The Essential Guide to <\/em>Requirements Management and Traceability<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 -->\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-87559'><div class='entry-content-wrapper clearfix'>\r\n\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef\">\n.avia-section.av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef{\nbackground-color:#7eda11;\nbackground:linear-gradient( to top right, #7eda11, #00adf6 );\nmargin-top:0px;\nmargin-bottom:0px;\n}\n<\/style>\n<div id='requirements-management-header'  class='avia-section av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef main_color avia-section-small avia-no-border-styling av-desktop-hide av-medium-hide 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src=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-80x80.png\" alt='' title='requirements management guide icon'  height=\"80\" width=\"80\" srcset=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-80x80.png 80w, https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon-150x150.png 150w, https:\/\/www.jamasoftware.com\/legacy\/media\/2021\/09\/requirements-management-guide-icon.png 272w\" sizes=\"(max-width: 80px) 100vw, 80px\" \/><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgcgdhku-707c6db513aef4676f39272a4957b4f4\">\n#top .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:20px;\n}\nbody .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag{\nfont-size:20px;\n}\n.av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 768px) and (max-width: 989px){ \n#top #wrap_all .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag{\nfont-size:20px;\n}\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag{\nfont-size:20px;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag{\nfont-size:20px;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 av-special-heading-h1 custom-color-heading blockquote modern-quote  left av-inherit-size'><h1 class='av-special-heading-tag '  ><em>The Essential Guide to <\/em>Requirements Management and Traceability<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 -->\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-87559'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-layout-grid-1'  class='av-layout-grid-container av-kt271a4m-10bb91fdac7866deb9b459933dd30004 entry-content-wrapper main_color av-flex-cells  avia-builder-el-1  el_after_av_repeatable_content  avia-builder-el-last  container grid-row-not-first  container_wrap sidebar_right'  >\n<div class='flex_cell av-9ly1rq-d271f8801eb2a31a37348c33d9260025 av-gridrow-cell av_one_fourth no_margin  avia-builder-el-2  el_before_av_cell_three_fourth  avia-builder-el-first '  ><div class='flex_cell_inner'><div  class='flex_column av-kscxjq-ef7413936882eee52a8ce740328b4938 av_one_full  avia-builder-el-3  avia-builder-el-no-sibling  first flex_column_div  '     ><section  class='av_textblock_section av-kt27dbgd-69e0ca3c07a4090259a3a00cfabffb24 '  ><div class='avia_textblock' ><div id=\"chapter-menu\" class=\"expand\"><h6>Chapters<\/h6><div class=\"menu-container\"><ul>\n\t\t\t\t<li id=\"requirements-management\" class=\"expand \">\n\t\t\t\t<strong>1.<\/strong> Requirements Management\n\t\t\t\t<\/li><div id=\"requirements-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/requirements-management\/\"> What is Requirements Management? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-do-you-need-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/why-do-you-need-requirements-management\/\"> Why do you need Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-fundamentals-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/four-fundamentals-of-requirements-management\/\"> Four Stages of Requirements Management Processes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-an-agile-approach-to-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/adopting-an-agile-approach-to-requirements-management\/\"> Adopting an Agile Approach to Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"status-requests-changes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/status-requests-changes\/\"> Status Request Changes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"conquering-the-5-biggest-challenges-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/conquering-the-5-biggest-challenges-of-requirements-management\/\"> Conquering the 5 Biggest Challenges of Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"three-reasons-you-need-a-requirements-management-solution\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/three-reasons-you-need-a-requirements-management-solution\/\"> Three Reasons You Need a Requirements Management Solution<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\/\"> Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management-plan\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/requirements-management-plan\/\"> What Is a Requirements Management Plan? A Practical Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"writing-requirements\" class=\"expand \">\n\t\t\t\t<strong>2.<\/strong> Writing Requirements\n\t\t\t\t<\/li><div id=\"writing-requirements\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-requirements-examples-and-templates\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/functional-requirements-examples-and-templates\/\"> Functional requirements examples and templates<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/product-requirements-document\/\"> What Is a Product Requirements Document? A Complete PRD Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"user-requirement-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/user-requirement-specification\/\"> What Is a User Requirement Specification (URS)? How to Write and Manage One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"identifying-and-measuring-the-quality-of-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/identifying-and-measuring-the-quality-of-requirements\/\"> Identifying and Measuring Requirements Quality<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-requirements-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/system-requirements-specification\/\"> How to Write a System Requirements Specification (SRS) Document<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\/\"> The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-risk-assessment\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/compliance-risk-assessment\/\"> What Is a Compliance Risk Assessment? Steps, Framework, and Examples<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-the-ears-notation-to-improve-requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/adopting-the-ears-notation-to-improve-requirements-engineering\/\"> Adopting the EARS Notation to Improve Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"jama-connect-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/jama-connect-advisor\/\"> Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\/\"> Frequently Asked Questions about the EARS Notation and Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-write-an-effective-product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/how-to-write-an-effective-product-requirements-document\/\"> How to Write an Effective Product Requirements Document (PRD)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-vs-non-functional-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/functional-vs-non-functional-requirements\/\"> Functional vs. Non-Functional Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-non-functional-requirements-impact-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/how-non-functional-requirements-impact-product-development\/\"> What Are Nonfunctional Requirements and How Do They Impact Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-design-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/software-design-specification\/\"> What Is a Software Design Specification? Key Components + Template<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-characteristics-of-excellent-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/the-characteristics-of-excellent-requirements\/\"> Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"8-dos-and-donts-for-writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/8-dos-and-donts-for-writing-requirements\/\"> 8 Do\u2019s and Don\u2019ts for Writing Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"project-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/project-requirements\/\"> Project Requirements: Types, Process, and Best Practices<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"expand \">\n\t\t\t\t<strong>3.<\/strong> Requirements Gathering and Management Processes\n\t\t\t\t<\/li><div id=\"requirements-gathering-and-management-processes\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-engineering\/\"> Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-analysis\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-analysis\/\"> Requirements Analysis<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"a-guide-to-requirements-elicitation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/a-guide-to-requirements-elicitation-for-product-teams\/\"> A Guide to Requirements Elicitation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-gathering-techniques-for-agile-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-gathering-techniques-for-agile-product-teams\/\"> Requirements Gathering Techniques for Agile Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-requirements-gathering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/what-is-requirements-gathering\/\"> Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"defining-and-implementing-requirements-baselines\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/defining-and-implementing-requirements-baselines\/\"> Defining and Implementing a Requirements Baseline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"managing-project-scope-why-it-matters-and-best-practices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/managing-project-scope-why-it-matters-and-best-practices\/\"> Managing Project Scope \u2014 Why It Matters and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-decomposition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-decomposition\/\"> Requirements Decomposition and How AI Supports It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-long-do-requirements-take\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-long-do-requirements-take\/\"> How Long Do Requirements Take?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-reuse-requirements-across-multiple-products\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-to-reuse-requirements-across-multiple-products\/\"> How to Reuse Requirements Across Multiple Products<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-prioritization-techniques\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-prioritization-techniques\/\"> Requirements Prioritization Techniques: 7 Methods for Engineers<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-traceability\" class=\"expand \">\n\t\t\t\t<strong>4.<\/strong> Requirements Traceability\n\t\t\t\t<\/li><div id=\"requirements-traceability\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability\/\"> What Is Traceability in Product Development? A Guide for Regulated Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tracing-your-way-to-success\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/tracing-your-way-to-success\/\"> Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bidirectional-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/bidirectional-traceability\/\"> Bidirectional Traceability: What It Is and How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"change-impact-analysis-cia-a-short-guide-for-effective-implementation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/change-impact-analysis-cia-a-short-guide-for-effective-implementation\/\"> Change Impact Analysis (CIA): A Short Guide for Effective Implementation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"engineering-change-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/engineering-change-management\/\"> What is Engineering Change Management (ECM)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-5\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-5\/\"> What is Meant by Version Control?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-7\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-7\/\"> Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-8\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-8\/\"> The Role of a Data Thread in Product and Software Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\/\"> Unraveling the Digital Thread: Enhancing Connectivity and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/traceability-matrix\/\"> What is a Traceability Matrix? A Guide to Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-create-and-use-a-requirements-traceability-matrix-rtm\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/how-to-create-and-use-a-requirements-traceability-matrix-rtm\/\"> How to Create and Use a Requirements Traceability Matrix (RTM)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-matrix-pros-and-cons\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-traceability-matrix-pros-and-cons\/\"> Requirements Traceability Matrix Pros and Cons: A Practical Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-13\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-13\/\"> Live Traceability vs. After-the-Fact Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"overcoming-barriers-live-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/overcoming-barriers-live-traceability\/\"> Overcoming Barriers to Live Requirements Traceability\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-15\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-15\/\"> Requirements Traceability, What Are You Missing?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-links-in-the-chain\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-traceability-links-in-the-chain\/\"> Requirements Traceability: Links in the Chain<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-are-the-benefits-of-end-to-end-traceability-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-are-the-benefits-of-end-to-end-traceability-in-product-development\/\"> What Are the Benefits of End-to-End Traceability During Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-volatility\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">18<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-volatility\/\"> Requirements Volatility: 7 Essential Management Strategies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"faqs-about-requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">19<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/faqs-about-requirements-traceability\/\"> FAQs About Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">20<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/ai-traceability\/\"> What Is AI Traceability? How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-traceability-regulated-industries\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">21<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/product-traceability-regulated-industries\/\"> Product Traceability for Regulated Industries: A Complete Guide to Audit-Ready Compliance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-information-model\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">22<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/traceability-information-model\/\"> What Is the Traceability Information Model?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"expand \">\n\t\t\t\t<strong>5.<\/strong> Requirements Management Tools and Software\n\t\t\t\t<\/li><div id=\"requirements-management-tools-and-software\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"selecting-the-right-requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/selecting-the-right-requirements-management-tools-and-software\/\"> Selecting the Right Requirements Management Tools and Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-investing-in-rm-software-makes-good-business-sense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/why-investing-in-rm-software-makes-good-business-sense\/\"> Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\/\"> Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-excel\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-excel\/\"> Can You Track Requirements in Excel?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"application-lifecycle-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/application-lifecycle-management\/\"> What Is Application Lifecycle Management (ALM)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"is-there-life-after-doors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/is-there-life-after-doors\/\"> Is There Life After DOORS\u00ae?\u00a0<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-jira\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-jira\/\"> Can You Track Requirements in Jira?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"checklist-selecting-a-requirements-management-tool\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/checklist-selecting-a-requirements-management-tool\/\"> Checklist: Selecting a Requirements Management Tool<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"expand \">\n\t\t\t\t<strong>6.<\/strong> Requirements Validation and Verification\n\t\t\t\t<\/li><div id=\"requirements-validation-and-verification\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-verification-and-validation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/requirements-verification-and-validation-for-product-teams\/\"> Requirements Verification and Validation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"best-practices-for-verification-and-validation-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/best-practices-for-verification-and-validation-in-product-development\/\"> Best Practices for Verification and Validation in Product Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-validation-and-traceability-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/requirements-validation-and-traceability-explained\/\"> Requirement Validation and Traceability Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-integration-testing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/system-integration-testing\/\"> What Is System Integration Testing (SIT)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand \">\n\t\t\t\t<strong>7.<\/strong> Meeting Regulatory Compliance and Industry Standards\n\t\t\t\t<\/li><div id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-standards\/\"> Understanding ISO Standards<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-iec-27001-a-guide-to-information-security-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-iec-27001-a-guide-to-information-security-management\/\"> Understanding ISO\/IEC 27001: A Guide to Information Security Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-devsecops-a-guide-to-building-secure-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/what-is-devsecops-a-guide-to-building-secure-software\/\"> What is DevSecOps? A Guide to Building Secure Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/compliance-management\/\"> Compliance Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fusa\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fusa\/\"> What Is Functional Safety (FuSa)? Standards, Lifecycle, and Where Programs Fail<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fmea\/\"> Failure Mode and Effects Analysis (FMEA) Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\/\"> T\u00dcV S\u00dcD: Ensuring Safety, Quality, and Sustainability Worldwide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62443\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iec-62443\/\"> What is IEC 62443? A Guide to Industrial Cybersecurity<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dfars-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/dfars-compliance\/\"> DFARS Compliance: A Guide for Defense Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"cmmc-vs-fedramp\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/cmmc-vs-fedramp\/\"> CMMC vs FedRAMP: What&#8217;s Different and Which One Applies to You<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"aspice\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/aspice\/\"> Automotive SPICE (ASPICE) 4.0: A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"rohs-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/rohs-compliance\/\"> Restriction of Hazardous Substances (RoHS) Compliance Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"misra-c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/misra-c\/\"> MISRA C and MISRA C++ Explained: Rules for Safer Embedded Code<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"reach-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/reach-compliance\/\"> REACH Compliance for Product Engineering Teams<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"systems-engineering\" class=\"expand \">\n\t\t\t\t<strong>8.<\/strong> Systems Engineering\n\t\t\t\t<\/li><div id=\"systems-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/what-is-systems-engineering\/\"> What is Systems Engineering? A Guide for Modern Engineering Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\/\"> How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-systems-engineering-body-of-knowledge-sebok\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/the-systems-engineering-body-of-knowledge-sebok\/\"> The Systems Engineering Body of Knowledge (SEBoK)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"model-based-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/model-based-systems-engineering\/\"> What Is MBSE? Model-Based Systems Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-between-government-and-contractors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/digital-engineering-between-government-and-contractors\/\"> Digital Engineering Between Government and Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\/\"> Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bom-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/bom-management\/\"> What Is Bill of Materials (BOM) Management? A Guide to Controlling Product Data<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"automotive-engineering\" class=\"expand \">\n\t\t\t\t<strong>9.<\/strong> Automotive Development\n\t\t\t\t<\/li><div id=\"automotive-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"automotive-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iatf-16949\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iatf-16949\/\"> Understanding IATF 16949: A Quick Guide to Automotive Quality Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-21434\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/iso-21434\/\"> What Is ISO 21434? Automotive Cybersecurity Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-26262\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/iso-26262\/\"> What Is ISO 26262? A Guide to Functional Safety in Automotive<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"asil\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/asil\/\"> What Is ASIL? A Guide to Automotive Safety Integrity Levels in ISO 26262<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"sotif\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/sotif\/\"> What Is SOTIF? A Guide to ISO 21448 for ADAS Safety<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"medical-devices\" class=\"expand \">\n\t\t\t\t<strong>10.<\/strong> Medical Device &#038; Life Sciences Development\n\t\t\t\t<\/li><div id=\"medical-devices\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"medical-devices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-importance-of-benefit-risk-analysis-in-medical-device-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/the-importance-of-benefit-risk-analysis-in-medical-device-development\/\"> The Importance of Benefit-Risk Analysis in Medical Device Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-as-a-medical-device-revolutionizing-healthcare\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/software-as-a-medical-device-revolutionizing-healthcare\/\"> Software as a Medical Device: Revolutionizing Healthcare<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"design-history-file-dhf\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/design-history-file-dhf\/\"> What\u2019s a Design History File, and How Are DHFs Used by Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\/\"> Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device &#038; Life Sciences Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iso-13485\/\"> What Is ISO 13485? A Guide to Medical Device Quality Management Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dmr-definition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/dmr-definition\/\"> What Is a Device Master Record (DMR)? Definition and FDA Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62304\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iec-62304\/\"> What Is IEC 62304? A Guide to Medical Device Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\/\"> ISO 13485 vs ISO 9001: Understanding the Differences and Synergies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\/\"> What You Need to Know: ANSI\/AAMI SW96:2023 \u2014 Medical Device Security<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\/\"> Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\/\"> Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"gspr\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/gspr\/\"> What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62366\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iec-62366\/\"> What Is IEC 62366? A Guide to Medical Device Usability Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"qmsr\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/qmsr\/\"> What Is the Quality Management System Regulation (QMSR)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"510k-vs-pma\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/510k-vs-pma\/\"> 510(k) vs PMA: Differences in FDA Device Approval and Clearance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"eu-mdr-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/eu-mdr-compliance\/\"> EU MDR Compliance Requirements and Timeline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"essential-performance-requirements\" class=\"active\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/essential-performance-requirements\/\"> Essential Performance Requirements and How to Identify Them<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"aerospace-and-defense\" class=\"expand \">\n\t\t\t\t<strong>11.<\/strong> Aerospace &#038; Defense Development\n\t\t\t\t<\/li><div id=\"aerospace-and-defense\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"aerospace-and-defense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"itar-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/itar-compliance\/\"> What is ITAR Compliance? What Engineering Teams Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-278a\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-278a\/\"> What Is DO-278A? A Guide for Compliance Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"safety-integrity-level\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/safety-integrity-level\/\"> What Is a Safety Integrity Level (SIL)? How to Calculate and Apply It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"arp4754a\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/arp4754a\/\"> What Is ARP4754A? A Complete Guide to Civil Aircraft and Systems Development Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\/\"> Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-254\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-254\/\"> What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-178c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-178c\/\"> What Is DO-178C? A Guide to Airborne Software Certification<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"expand \">\n\t\t\t\t<strong>12.<\/strong> Architecture, Engineering, and Construction (AEC industry) Development\n\t\t\t\t<\/li><div id=\"architecture-engineering-and-construction-aec-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-the-aec-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/what-is-the-aec-industry\/\"> What is the AEC Industry?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"expand \">\n\t\t\t\t<strong>13.<\/strong> Industrial Manufacturing &#038; Machinery, Automation &#038; Robotics, Consumer Electronics, and Energy\n\t\t\t\t<\/li><div id=\"industrial-manufacturing-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-61508\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iec-61508\/\"> What Is IEC 61508? A Guide to the Functional Safety Standard<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\/\"> Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62061-functional-safety-for-machinery-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iec-62061-functional-safety-for-machinery-systems\/\"> IEC 62061 \u2013 Functional Safety for Machinery Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-10218-ensuring-safety-in-industrial-robotics\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iso-10218-ensuring-safety-in-industrial-robotics\/\"> ISO 10218: Ensuring Safety in Industrial Robotics<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"semiconductor\" class=\"expand \">\n\t\t\t\t<strong>14.<\/strong> Semiconductor Development\n\t\t\t\t<\/li><div id=\"semiconductor\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"semiconductor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-chiplets-are-changing-the-game-in-tech-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/why-chiplets-are-changing-the-game-in-tech-innovation\/\"> Why Chiplets Are Changing the Game in Tech Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\/\"> Integrating Digital Engineering and the Digital Thread for Semiconductor Design<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"expand \">\n\t\t\t\t<strong>15.<\/strong> AI in Product Development\n\t\t\t\t<\/li><div id=\"artificial-intelligence-in-product-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/ai-in-product-development\/\"> What Is AI in Product Development? A Complete 2026 Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-test-case-generation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/ai-in-product-development\/ai-test-case-generation\/\"> AI Test Case Generation: A Complete Guide for Regulated QA Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"using-ai-to-write-software-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/using-ai-to-write-software-requirements\/\"> Using AI to Write Software Requirements: What Works and What Doesn&#8217;t<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"mcp-for-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/mcp-for-requirements-management\/\"> What Is the Model Context Protocol (MCP) for Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-for-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/ai-for-systems-engineering\/\"> AI for Systems Engineering: Benefits, Risks, and How to Start<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-automation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/requirements-automation\/\"> How to Automate Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/artificial-intelligence-in-requirements-management\/\"> Artificial Intelligence in Requirements Management<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"risk-management\" class=\"expand \">\n\t\t\t\t<strong>16.<\/strong> Risk Management\n\t\t\t\t<\/li><div id=\"risk-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/failure-modes\/\"> What Are Failure Modes? Types, Examples, and How to Identify Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/software-risk-management\/\"> What Is Software Risk Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"risk-assessment-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/risk-assessment-matrix\/\"> What Is a Risk Assessment Matrix? How to Build and Use One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"types-of-fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/types-of-fmea\/\"> Types of FMEA: Definitions, Differences, and When to Use Each<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"expand \">\n\t\t\t\t<strong>17.<\/strong> Product Development Terms and Definitions\n\t\t\t\t<\/li><div id=\"product-development-terms-and-definitions\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"concurrent-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/concurrent-engineering\/\"> Concurrent Engineering: Benefits, Challenges, and Best Practices<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div><\/ul><div class=\"clear\"><\/div><\/div><\/div><p class=\"mobile-breadcrumb\"><span class=\"border\">Chapter 10<\/span>: Essential Performance Requirements and How to Identify Them<\/p><div class=\"mobile-menu\"><div id=\"chapter-menu\" class=\"expand\"><h6>Chapters<\/h6><div class=\"menu-container\"><ul>\n\t\t\t\t<li id=\"requirements-management\" class=\"expand \">\n\t\t\t\t<strong>1.<\/strong> Requirements Management\n\t\t\t\t<\/li><div id=\"requirements-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/requirements-management\/\"> What is Requirements Management? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-do-you-need-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/why-do-you-need-requirements-management\/\"> Why do you need Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-fundamentals-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/four-fundamentals-of-requirements-management\/\"> Four Stages of Requirements Management Processes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-an-agile-approach-to-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/adopting-an-agile-approach-to-requirements-management\/\"> Adopting an Agile Approach to Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"status-requests-changes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/status-requests-changes\/\"> Status Request Changes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"conquering-the-5-biggest-challenges-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/conquering-the-5-biggest-challenges-of-requirements-management\/\"> Conquering the 5 Biggest Challenges of Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"three-reasons-you-need-a-requirements-management-solution\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/three-reasons-you-need-a-requirements-management-solution\/\"> Three Reasons You Need a Requirements Management Solution<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\/\"> Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management-plan\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management\/requirements-management-plan\/\"> What Is a Requirements Management Plan? A Practical Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"writing-requirements\" class=\"expand \">\n\t\t\t\t<strong>2.<\/strong> Writing Requirements\n\t\t\t\t<\/li><div id=\"writing-requirements\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-requirements-examples-and-templates\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/functional-requirements-examples-and-templates\/\"> Functional requirements examples and templates<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/product-requirements-document\/\"> What Is a Product Requirements Document? A Complete PRD Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"user-requirement-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/user-requirement-specification\/\"> What Is a User Requirement Specification (URS)? How to Write and Manage One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"identifying-and-measuring-the-quality-of-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/identifying-and-measuring-the-quality-of-requirements\/\"> Identifying and Measuring Requirements Quality<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-requirements-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/system-requirements-specification\/\"> How to Write a System Requirements Specification (SRS) Document<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\/\"> The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-risk-assessment\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/compliance-risk-assessment\/\"> What Is a Compliance Risk Assessment? Steps, Framework, and Examples<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-the-ears-notation-to-improve-requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/adopting-the-ears-notation-to-improve-requirements-engineering\/\"> Adopting the EARS Notation to Improve Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"jama-connect-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/jama-connect-advisor\/\"> Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\/\"> Frequently Asked Questions about the EARS Notation and Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-write-an-effective-product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/how-to-write-an-effective-product-requirements-document\/\"> How to Write an Effective Product Requirements Document (PRD)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-vs-non-functional-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/functional-vs-non-functional-requirements\/\"> Functional vs. Non-Functional Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-non-functional-requirements-impact-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/how-non-functional-requirements-impact-product-development\/\"> What Are Nonfunctional Requirements and How Do They Impact Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-design-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/software-design-specification\/\"> What Is a Software Design Specification? Key Components + Template<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-characteristics-of-excellent-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/the-characteristics-of-excellent-requirements\/\"> Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"8-dos-and-donts-for-writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/8-dos-and-donts-for-writing-requirements\/\"> 8 Do\u2019s and Don\u2019ts for Writing Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"project-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/writing-requirements\/project-requirements\/\"> Project Requirements: Types, Process, and Best Practices<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"expand \">\n\t\t\t\t<strong>3.<\/strong> Requirements Gathering and Management Processes\n\t\t\t\t<\/li><div id=\"requirements-gathering-and-management-processes\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-engineering\/\"> Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-analysis\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-analysis\/\"> Requirements Analysis<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"a-guide-to-requirements-elicitation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/a-guide-to-requirements-elicitation-for-product-teams\/\"> A Guide to Requirements Elicitation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-gathering-techniques-for-agile-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-gathering-techniques-for-agile-product-teams\/\"> Requirements Gathering Techniques for Agile Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-requirements-gathering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/what-is-requirements-gathering\/\"> Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"defining-and-implementing-requirements-baselines\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/defining-and-implementing-requirements-baselines\/\"> Defining and Implementing a Requirements Baseline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"managing-project-scope-why-it-matters-and-best-practices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/managing-project-scope-why-it-matters-and-best-practices\/\"> Managing Project Scope \u2014 Why It Matters and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-decomposition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-decomposition\/\"> Requirements Decomposition and How AI Supports It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-long-do-requirements-take\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-long-do-requirements-take\/\"> How Long Do Requirements Take?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-reuse-requirements-across-multiple-products\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-to-reuse-requirements-across-multiple-products\/\"> How to Reuse Requirements Across Multiple Products<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-prioritization-techniques\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-prioritization-techniques\/\"> Requirements Prioritization Techniques: 7 Methods for Engineers<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-traceability\" class=\"expand \">\n\t\t\t\t<strong>4.<\/strong> Requirements Traceability\n\t\t\t\t<\/li><div id=\"requirements-traceability\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability\/\"> What Is Traceability in Product Development? A Guide for Regulated Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tracing-your-way-to-success\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/tracing-your-way-to-success\/\"> Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bidirectional-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/bidirectional-traceability\/\"> Bidirectional Traceability: What It Is and How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"change-impact-analysis-cia-a-short-guide-for-effective-implementation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/change-impact-analysis-cia-a-short-guide-for-effective-implementation\/\"> Change Impact Analysis (CIA): A Short Guide for Effective Implementation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"engineering-change-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/engineering-change-management\/\"> What is Engineering Change Management (ECM)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-5\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-5\/\"> What is Meant by Version Control?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-7\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-7\/\"> Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-8\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-8\/\"> The Role of a Data Thread in Product and Software Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\/\"> Unraveling the Digital Thread: Enhancing Connectivity and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/traceability-matrix\/\"> What is a Traceability Matrix? A Guide to Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-create-and-use-a-requirements-traceability-matrix-rtm\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/how-to-create-and-use-a-requirements-traceability-matrix-rtm\/\"> How to Create and Use a Requirements Traceability Matrix (RTM)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-matrix-pros-and-cons\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-traceability-matrix-pros-and-cons\/\"> Requirements Traceability Matrix Pros and Cons: A Practical Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-13\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-13\/\"> Live Traceability vs. After-the-Fact Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"overcoming-barriers-live-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/overcoming-barriers-live-traceability\/\"> Overcoming Barriers to Live Requirements Traceability\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-15\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-is-traceability-15\/\"> Requirements Traceability, What Are You Missing?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-links-in-the-chain\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-traceability-links-in-the-chain\/\"> Requirements Traceability: Links in the Chain<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-are-the-benefits-of-end-to-end-traceability-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/what-are-the-benefits-of-end-to-end-traceability-in-product-development\/\"> What Are the Benefits of End-to-End Traceability During Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-volatility\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">18<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/requirements-volatility\/\"> Requirements Volatility: 7 Essential Management Strategies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"faqs-about-requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">19<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/faqs-about-requirements-traceability\/\"> FAQs About Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">20<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/ai-traceability\/\"> What Is AI Traceability? How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-traceability-regulated-industries\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">21<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/product-traceability-regulated-industries\/\"> Product Traceability for Regulated Industries: A Complete Guide to Audit-Ready Compliance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-information-model\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">22<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-traceability\/traceability-information-model\/\"> What Is the Traceability Information Model?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"expand \">\n\t\t\t\t<strong>5.<\/strong> Requirements Management Tools and Software\n\t\t\t\t<\/li><div id=\"requirements-management-tools-and-software\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"selecting-the-right-requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/selecting-the-right-requirements-management-tools-and-software\/\"> Selecting the Right Requirements Management Tools and Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-investing-in-rm-software-makes-good-business-sense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/why-investing-in-rm-software-makes-good-business-sense\/\"> Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\/\"> Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-excel\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-excel\/\"> Can You Track Requirements in Excel?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"application-lifecycle-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/application-lifecycle-management\/\"> What Is Application Lifecycle Management (ALM)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"is-there-life-after-doors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/is-there-life-after-doors\/\"> Is There Life After DOORS\u00ae?\u00a0<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-jira\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-jira\/\"> Can You Track Requirements in Jira?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"checklist-selecting-a-requirements-management-tool\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-management-tools-and-software\/checklist-selecting-a-requirements-management-tool\/\"> Checklist: Selecting a Requirements Management Tool<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"expand \">\n\t\t\t\t<strong>6.<\/strong> Requirements Validation and Verification\n\t\t\t\t<\/li><div id=\"requirements-validation-and-verification\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-verification-and-validation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/requirements-verification-and-validation-for-product-teams\/\"> Requirements Verification and Validation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"best-practices-for-verification-and-validation-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/best-practices-for-verification-and-validation-in-product-development\/\"> Best Practices for Verification and Validation in Product Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-validation-and-traceability-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/requirements-validation-and-traceability-explained\/\"> Requirement Validation and Traceability Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-integration-testing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/requirements-validation-and-verification\/system-integration-testing\/\"> What Is System Integration Testing (SIT)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand \">\n\t\t\t\t<strong>7.<\/strong> Meeting Regulatory Compliance and Industry Standards\n\t\t\t\t<\/li><div id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-standards\/\"> Understanding ISO Standards<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-iec-27001-a-guide-to-information-security-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-iec-27001-a-guide-to-information-security-management\/\"> Understanding ISO\/IEC 27001: A Guide to Information Security Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-devsecops-a-guide-to-building-secure-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/what-is-devsecops-a-guide-to-building-secure-software\/\"> What is DevSecOps? A Guide to Building Secure Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/compliance-management\/\"> Compliance Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fusa\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fusa\/\"> What Is Functional Safety (FuSa)? Standards, Lifecycle, and Where Programs Fail<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fmea\/\"> Failure Mode and Effects Analysis (FMEA) Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\/\"> T\u00dcV S\u00dcD: Ensuring Safety, Quality, and Sustainability Worldwide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62443\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iec-62443\/\"> What is IEC 62443? A Guide to Industrial Cybersecurity<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dfars-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/dfars-compliance\/\"> DFARS Compliance: A Guide for Defense Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"cmmc-vs-fedramp\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/cmmc-vs-fedramp\/\"> CMMC vs FedRAMP: What&#8217;s Different and Which One Applies to You<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"aspice\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/aspice\/\"> Automotive SPICE (ASPICE) 4.0: A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"rohs-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/rohs-compliance\/\"> Restriction of Hazardous Substances (RoHS) Compliance Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"misra-c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/misra-c\/\"> MISRA C and MISRA C++ Explained: Rules for Safer Embedded Code<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"reach-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/reach-compliance\/\"> REACH Compliance for Product Engineering Teams<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"systems-engineering\" class=\"expand \">\n\t\t\t\t<strong>8.<\/strong> Systems Engineering\n\t\t\t\t<\/li><div id=\"systems-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/what-is-systems-engineering\/\"> What is Systems Engineering? A Guide for Modern Engineering Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\/\"> How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-systems-engineering-body-of-knowledge-sebok\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/the-systems-engineering-body-of-knowledge-sebok\/\"> The Systems Engineering Body of Knowledge (SEBoK)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"model-based-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/model-based-systems-engineering\/\"> What Is MBSE? Model-Based Systems Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-between-government-and-contractors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/digital-engineering-between-government-and-contractors\/\"> Digital Engineering Between Government and Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\/\"> Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bom-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/systems-engineering\/bom-management\/\"> What Is Bill of Materials (BOM) Management? A Guide to Controlling Product Data<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"automotive-engineering\" class=\"expand \">\n\t\t\t\t<strong>9.<\/strong> Automotive Development\n\t\t\t\t<\/li><div id=\"automotive-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"automotive-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iatf-16949\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iatf-16949\/\"> Understanding IATF 16949: A Quick Guide to Automotive Quality Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-21434\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/iso-21434\/\"> What Is ISO 21434? Automotive Cybersecurity Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-26262\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/iso-26262\/\"> What Is ISO 26262? A Guide to Functional Safety in Automotive<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"asil\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/asil\/\"> What Is ASIL? A Guide to Automotive Safety Integrity Levels in ISO 26262<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"sotif\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/automotive-engineering\/sotif\/\"> What Is SOTIF? A Guide to ISO 21448 for ADAS Safety<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"medical-devices\" class=\"expand \">\n\t\t\t\t<strong>10.<\/strong> Medical Device &#038; Life Sciences Development\n\t\t\t\t<\/li><div id=\"medical-devices\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"medical-devices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-importance-of-benefit-risk-analysis-in-medical-device-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/the-importance-of-benefit-risk-analysis-in-medical-device-development\/\"> The Importance of Benefit-Risk Analysis in Medical Device Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-as-a-medical-device-revolutionizing-healthcare\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/software-as-a-medical-device-revolutionizing-healthcare\/\"> Software as a Medical Device: Revolutionizing Healthcare<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"design-history-file-dhf\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/design-history-file-dhf\/\"> What\u2019s a Design History File, and How Are DHFs Used by Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\/\"> Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device &#038; Life Sciences Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iso-13485\/\"> What Is ISO 13485? A Guide to Medical Device Quality Management Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dmr-definition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/dmr-definition\/\"> What Is a Device Master Record (DMR)? Definition and FDA Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62304\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iec-62304\/\"> What Is IEC 62304? A Guide to Medical Device Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\/\"> ISO 13485 vs ISO 9001: Understanding the Differences and Synergies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\/\"> What You Need to Know: ANSI\/AAMI SW96:2023 \u2014 Medical Device Security<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\/\"> Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\/\"> Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"gspr\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/gspr\/\"> What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62366\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/iec-62366\/\"> What Is IEC 62366? A Guide to Medical Device Usability Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"qmsr\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/qmsr\/\"> What Is the Quality Management System Regulation (QMSR)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"510k-vs-pma\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/510k-vs-pma\/\"> 510(k) vs PMA: Differences in FDA Device Approval and Clearance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"eu-mdr-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/eu-mdr-compliance\/\"> EU MDR Compliance Requirements and Timeline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"essential-performance-requirements\" class=\"active\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/medical-devices\/essential-performance-requirements\/\"> Essential Performance Requirements and How to Identify Them<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"aerospace-and-defense\" class=\"expand \">\n\t\t\t\t<strong>11.<\/strong> Aerospace &#038; Defense Development\n\t\t\t\t<\/li><div id=\"aerospace-and-defense\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"aerospace-and-defense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"itar-compliance\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/itar-compliance\/\"> What is ITAR Compliance? What Engineering Teams Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-278a\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-278a\/\"> What Is DO-278A? A Guide for Compliance Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"safety-integrity-level\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/safety-integrity-level\/\"> What Is a Safety Integrity Level (SIL)? How to Calculate and Apply It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"arp4754a\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/arp4754a\/\"> What Is ARP4754A? A Complete Guide to Civil Aircraft and Systems Development Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\/\"> Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-254\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-254\/\"> What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-178c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/aerospace-and-defense\/do-178c\/\"> What Is DO-178C? A Guide to Airborne Software Certification<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"expand \">\n\t\t\t\t<strong>12.<\/strong> Architecture, Engineering, and Construction (AEC industry) Development\n\t\t\t\t<\/li><div id=\"architecture-engineering-and-construction-aec-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-the-aec-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/what-is-the-aec-industry\/\"> What is the AEC Industry?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"expand \">\n\t\t\t\t<strong>13.<\/strong> Industrial Manufacturing &#038; Machinery, Automation &#038; Robotics, Consumer Electronics, and Energy\n\t\t\t\t<\/li><div id=\"industrial-manufacturing-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-61508\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iec-61508\/\"> What Is IEC 61508? A Guide to the Functional Safety Standard<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\/\"> Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62061-functional-safety-for-machinery-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iec-62061-functional-safety-for-machinery-systems\/\"> IEC 62061 \u2013 Functional Safety for Machinery Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-10218-ensuring-safety-in-industrial-robotics\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/industrial-manufacturing-development\/iso-10218-ensuring-safety-in-industrial-robotics\/\"> ISO 10218: Ensuring Safety in Industrial Robotics<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"semiconductor\" class=\"expand \">\n\t\t\t\t<strong>14.<\/strong> Semiconductor Development\n\t\t\t\t<\/li><div id=\"semiconductor\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"semiconductor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-chiplets-are-changing-the-game-in-tech-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/why-chiplets-are-changing-the-game-in-tech-innovation\/\"> Why Chiplets Are Changing the Game in Tech Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/semiconductor\/integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\/\"> Integrating Digital Engineering and the Digital Thread for Semiconductor Design<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"expand \">\n\t\t\t\t<strong>15.<\/strong> AI in Product Development\n\t\t\t\t<\/li><div id=\"artificial-intelligence-in-product-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/ai-in-product-development\/\"> What Is AI in Product Development? A Complete 2026 Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-test-case-generation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/ai-in-product-development\/ai-test-case-generation\/\"> AI Test Case Generation: A Complete Guide for Regulated QA Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"using-ai-to-write-software-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/using-ai-to-write-software-requirements\/\"> Using AI to Write Software Requirements: What Works and What Doesn&#8217;t<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"mcp-for-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/mcp-for-requirements-management\/\"> What Is the Model Context Protocol (MCP) for Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"ai-for-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/ai-for-systems-engineering\/\"> AI for Systems Engineering: Benefits, Risks, and How to Start<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-automation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/requirements-automation\/\"> How to Automate Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/artificial-intelligence-in-product-development\/artificial-intelligence-in-requirements-management\/\"> Artificial Intelligence in Requirements Management<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"risk-management\" class=\"expand \">\n\t\t\t\t<strong>16.<\/strong> Risk Management\n\t\t\t\t<\/li><div id=\"risk-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/failure-modes\/\"> What Are Failure Modes? Types, Examples, and How to Identify Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/software-risk-management\/\"> What Is Software Risk Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"risk-assessment-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/risk-assessment-matrix\/\"> What Is a Risk Assessment Matrix? How to Build and Use One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"types-of-fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/risk-management\/types-of-fmea\/\"> Types of FMEA: Definitions, Differences, and When to Use Each<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"expand \">\n\t\t\t\t<strong>17.<\/strong> Product Development Terms and Definitions\n\t\t\t\t<\/li><div id=\"product-development-terms-and-definitions\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"concurrent-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/concurrent-engineering\/\"> Concurrent Engineering: Benefits, Challenges, and Best Practices<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div><\/ul><div class=\"clear\"><\/div><\/div><\/div><\/div>\n<\/div><\/section><\/div>\n<\/div><\/div><div class='flex_cell av-1vxh1fa-162c0e8fab30caffb39fc6a716745c9c av-gridrow-cell av_three_fourth no_margin'  ><div class='flex_cell_inner'><p><div  class='flex_column av-6bv6cfe-0bca5ea9eb71366ffef3ca20d8dcdefa av_one_full first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mnowyy8b-ca982bb9417e7f25f425b17618113255\">\n#top .av_textblock_section.av-mnowyy8b-ca982bb9417e7f25f425b17618113255 .avia_textblock{\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-mnowyy8b-ca982bb9417e7f25f425b17618113255 '  ><div class='avia_textblock av_inherit_color' ><h1><b>Essential Performance Requirements and How to Identify Them<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">A patient hoist performs two clinical functions, raising a patient and lowering one. A risk analysis may accept a hoist&#8217;s failure to lift a patient while treating failure to lower the patient as unacceptable risk. In that analysis, only the lowering function qualifies as essential performance.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That asymmetry sits at the center of essential performance analysis. The manufacturer leads the risk-based determination. In some cases, the manufacturer may conclude the device has no essential performance. Essential performance analysis separates clinical function risk from basic safety risk and anchors the determination within <\/span><a href=\"https:\/\/www.jamasoftware.com\/blog\/2020\/06\/08\/iso-14971\/\"><span style=\"font-weight: 400;\">ISO 14971 risk analysis<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This guide covers how essential performance differs from basic safety, how to identify it through risk analysis, and how to test, document, and maintain it as designs change.<\/span><\/p>\n<h2><b>What Is an Essential Performance Requirement?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">IEC 60601-1 defines essential performance as the performance of a clinical function whose loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk. That definition gives teams a direct screening question. Would the function&#8217;s absence or degradation cross the manufacturer&#8217;s acceptable-risk threshold?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">An essential performance requirement (EPR) is a documented requirement that captures the clinical function, its performance limits, and the conditions under which those limits apply. Essential performance became a compliance requirement through an amendment to IEC 60601-1. Manufacturers must establish specific performance limits, evaluate essential performance characteristics under abnormal or fault conditions, and declare specific essential performance criteria in the product&#8217;s technical description.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Those limits must sit between fully functional and total loss of the identified performance, under both normal and single-fault conditions. The standard notes that the limits can differ between the two conditions. The current Edition 3.2 was published in August 2020, and its requirements have been in effect for <\/span><a href=\"https:\/\/ramtechno.com\/updates-to-iec-standard-60601-1-3-2-normative-references\/\"><span style=\"font-weight: 400;\">U.S. certification since December 17, 2023<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><b>Essential Performance vs. Basic Safety and the Difference<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Every requirement in IEC 60601-1 serves one or both of two objectives, basic safety and essential performance. The two concepts answer different questions about the same device.<\/span><\/p>\n<h3><b>How IEC 60601-1 Defines Basic Safety<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Basic safety covers unacceptable risk directly caused by the device&#8217;s physical hazards under normal and single-fault conditions. The physical hazards inherent to the device are electric shock, thermal hazards, and mechanical hazards. Manufacturers typically address them through passive protective measures such as electrical insulation, thermal fuses, and fireproof casings.<\/span><\/p>\n<h3><b>Why Clinical Function Is the Dividing Line<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Essential performance concerns whether the device delivers its intended clinical benefit. Above that threshold, the harm comes from the failure to treat, monitor, or diagnose. The device&#8217;s own physical hazards fall under basic safety. Clinical functions include therapeutic and patient-monitoring functions, along with diagnostic functions built into the equipment itself, such as imaging or waveform analysis. Standalone in vitro diagnostic devices fall outside this scope, as covered below. The split is easiest to see in devices that carry both dimensions at once.<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Dimension<\/b><\/td>\n<td><b>Defibrillator<\/b><\/td>\n<td><b>Infusion pump<\/b><\/td>\n<td><b>Blood pressure monitor<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Basic safety<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Electrical safety of the discharge circuit<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Enclosure and electrical insulation<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Insulation and touch-current limits<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Essential performance<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Delivering the correct energy level to restart the heart<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Dose delivery within specified accuracy limits<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Accurate measurement and display of blood pressure<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Both dimensions must survive single fault condition testing. The tested failure differs. One protects against a physical hazard, the other confirms continued delivery of the clinical function.<\/span><\/p>\n<h2><b>How to Identify Essential Performance Requirements<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Manufacturers identify essential performance through a risk management process that complies with ISO 14971. Essential performance identification must connect directly to risk management under IEC 60601-1.<\/span><\/p>\n<h3><b>Starting With a Risk-Based Assessment Under ISO 14971<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Identification starts by enumerating every clinical function the device performs, then treating the loss or degradation of each as a potential source of harm. Manufacturers must identify and document known and foreseeable hazards based on the device&#8217;s safety characteristics across the intended use and reasonably foreseeable misuse, under both normal and fault conditions, as required by ISO 14971. A risk analysis limited to component failures will miss functions that drift out of specification during ordinary operation, so the normal-condition analysis has to be included.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Teams can use guidance questions from the companion technical report, ISO\/TR 24971, to identify device characteristics that affect safety. Those questions help teams avoid narrowing the analysis too early.<\/span><\/p>\n<h3><b>Mapping Each Clinical Function to Its Risk<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">For each function, teams ask whether operation beyond specified performance levels would result in harm. The performance range at which harm occurs establishes the essential performance limits, and if variation in the function doesn&#8217;t result in injury, it isn&#8217;t essential performance. The manufacturer&#8217;s documented policy defines acceptable risk levels.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Teams should assess essential performance before applying risk control measures, because the essential performance they define determines those controls. Assessing after mitigation inverts the logic.<\/span><\/p>\n<h3><b>Common Tools for Essential Performance Risk Analysis<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Manufacturers choose risk analysis techniques that fit the device and hazard profile. ISO\/TR 24971 lists methods such as the following:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Failure Mode and Effects Analysis (FMEA):<\/b><span style=\"font-weight: 400;\"> A bottom-up method that starts from components and failure modes and works toward hazards. FMEA only identifies risks associated with fault conditions, so it can&#8217;t be the sole tool for an analysis that must also cover normal operation.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Fault Tree Analysis (FTA):<\/b><span style=\"font-weight: 400;\"> A top-down method that starts from a defined top event, such as loss of accurate drug delivery. It decomposes the event into contributing failure combinations with AND and OR gates. Minimal cut sets expose single points of failure threatening an essential performance function.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Hazard and Operability Analysis:<\/b><span style=\"font-weight: 400;\"> A guide-word technique that examines deviations from design intent. Guide words such as &#8220;more than,&#8221; &#8220;less than,&#8221; and &#8220;no flow&#8221; map directly onto loss or degradation of essential performance.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The directional differences explain why teams combine methods rather than pick one. Running both against the same function surfaces failure paths that a single technique alone would miss.<\/span><\/p>\n<h3><b>Deciding When a Device Has No Essential Performance<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">When the evidence supports no essential performance, the team still follows the same analysis as any other outcome. The same sequence applies when the team believes no essential performance exists:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">All functions of the device are listed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Non-clinical functions are removed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Functions outside the intended use are removed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Loss or degradation of each remaining function is assessed for unacceptable risk.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Every function that fails that test is identified as essential performance.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Caution is warranted with backup-system arguments, because the risk analysis still needs to account for harm the primary system may cause before the backup engages. Auditors may scrutinize a bare no-essential-performance statement, so the supporting risk assessment must be retrievable when a test laboratory or regulator requests it.<\/span><\/p>\n<h2><b>How to Test and Document Essential Performance Requirements<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Identifying an EPR creates testing and documentation obligations that follow the device through certification and beyond. Each requirement needs preplanned acceptance criteria, standards mapping, and traceability to verification evidence.<\/span><\/p>\n<h3><b>Setting Acceptance Criteria for Each EPR<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Pass\/fail criteria for immunity testing must be quantitative, specific to the medical device and its functions, observable, and documented in the electromagnetic compatibility (EMC) test plan before testing begins. Criteria defined after the fact invite challenge during regulatory review. Essential performance and basic safety must not be affected by electromagnetic disturbances under IEC 60601-1-2, the EMC collateral standard, and degradation that produces unacceptable risk isn&#8217;t allowed, even when an alarm accompanies it.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Measurable criteria can include the accuracy of a life-supporting function and the correct operation of an alarm whose failure would pose an unacceptable risk. Teams should make the required performance limit testable before laboratory work starts.<\/span><\/p>\n<h3><b>Mapping EPRs to Applicable Standards<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">For covered device types, particular standards name essential performance explicitly and are the first place to look. For infusion pumps, a later edition of IEC 60601-2-24 added a table of EPRs where an earlier edition had none. Defibrillator EPR areas include charging time, endurance, synchronizer function, and recovery of electrocardiogram (ECG) inputs after defibrillation, as identified in EN 60601-2-4.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A pulse oximeter&#8217;s essential performance is the accuracy of peripheral oxygen saturation (SpO2) and pulse rate, or an indication of abnormal operation, under ISO 80601-2-61. Where no particular standard applies, risk assessment and knowledge of predicate devices define essential performance. If a particular standard specifies no additional essential performance requirements, the manufacturer reverts to the general standard.<\/span><\/p>\n<h3><b>Recording Rationale for Audit and Regulatory Review<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">For audit and regulatory review, the risk management file should connect essential performance, failure modes, risk controls, and verification results. Each identified hazard must be traceable in accordance with ISO 14971. Reviewers evaluate the whole file for consistency, and non-conformities often cluster at document interfaces. The auditable chain needs to hold at each interface:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Hazard to risk control:<\/b><span style=\"font-weight: 400;\"> each identified hazard links to the risk control that mitigates it.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Risk control to requirement:<\/b><span style=\"font-weight: 400;\"> each risk control links to the requirement that implements it.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Requirement-to-test result:<\/b><span style=\"font-weight: 400;\"> each requirement links to the test protocol and the pass\/fail result that verifies it.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The chain looks largely the same across U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulation (EU MDR) reviews. Keeping those links current makes the rationale easier to defend.<\/span><\/p>\n<h2><b>Common Challenges When Defining Essential Performance<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Teams that run the risk process correctly still stumble on recurring problems. Essential performance can sit in supporting functions, connected products, and later design changes.<\/span><\/p>\n<h3><b>Overlooking Secondary or Monitoring Functions<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Alarm functions can be essential to the performance of devices such as patient monitors, neonatal warmers and incubators, anesthesia delivery systems, dialysis machines, infusion pumps, and ventilators. Raising visual and auditory alarms to alert caregivers is itself a clinical function whose loss can create unacceptable risk. Later editions of IEC 60601-1 expanded the scope to capture performance such as the accuracy of physiological monitoring equipment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Identification has to cover supporting functions as well as the primary therapeutic one. Otherwise, teams can miss the function that distinguishes safe intervention from delayed response.<\/span><\/p>\n<h3><b>Added Complexity in Combination Products<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Drug-device combination products can carry a second layer of analysis, because teams need to assess, characterize, and control interactions of the constituent parts in addition to the parts themselves. EPRs for combination products are<\/span><a href=\"https:\/\/www.jamasoftware.com\/blog\/2020\/06\/18\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\/\"> <span style=\"font-weight: 400;\">design input requirements<\/span><\/a><span style=\"font-weight: 400;\"> for safe and effective operation, and they&#8217;re usually a subset of Critical Quality Attributes (CQAs) in drug Quality by Design language.<\/span><\/p>\n<h3><b>Keeping EPRs Current Through Design Changes<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Any change to a device&#8217;s intended use can change its essential performance, and a predicate device with essential performance can create the expectation that yours will need it too. Alarm system changes sit in the same trap, since teams must assess the significance of removing, adding, or modifying alarm handling. Teams that push alarm changes through routine<\/span><a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/reguirements-traceability\/change-impact-analysis-cia-a-short-guide-for-effective-implementation\/\"> <span style=\"font-weight: 400;\">engineering change orders<\/span><\/a><span style=\"font-weight: 400;\"> without an essential performance impact assessment create a documented compliance gap.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Retroactive documentation of changes can become an audit finding. A living essential performance analysis makes those impacts easier to spot before the record falls behind the design.<\/span><\/p>\n<h2><b>How Jama Connect Supports Essential Performance Requirements<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">When EPR artifacts live in disconnected spreadsheets,<\/span><a href=\"https:\/\/help.jamasoftware.com\/\"> <span style=\"font-weight: 400;\">Jama Connect\u00ae<\/span><\/a><span style=\"font-weight: 400;\"> can support regulated teams by keeping risk activities such as FMEA and hazard analysis alongside the requirements they trace to. Its medical device framework is aligned to ISO 13485, IEC 62304, ISO 14971, and FDA design controls.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When designs change,<\/span><a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-are-the-benefits-of-end-to-end-traceability-in-product-development\/\"> <span style=\"font-weight: 400;\">Live Traceability\u2122<\/span><\/a><span style=\"font-weight: 400;\"> helps keep requirements, risk records, design outputs, and test evidence connected. If an essential performance limit changes, suspect links flag linked<\/span><a href=\"https:\/\/help.jamasoftware.com\/ah\/en\/test.html\"> <span style=\"font-weight: 400;\">test cases<\/span><\/a><span style=\"font-weight: 400;\"> and risk assessments for review before the gap becomes a finding.<\/span><\/p>\n<h2><b>Keep Essential Performance Requirements Audit Ready<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Changes to standards and design inputs can alter EPRs after release. Intended-use changes can do the same. Teams should keep the hazard-to-requirement-to-test rationale up to date as those inputs evolve.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If your team is still rebuilding traceability before each audit, Jama Connect helps keep requirements, risks, and tests connected in one place. You can see how connected requirements, risks, and tests work together with a<\/span><a href=\"https:\/\/www.jamasoftware.com\/platform\/jama-connect\/trial\/?utm_campaign=cta+blog\"> <span style=\"font-weight: 400;\">free trial of Jama Connect<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><b>Frequently Asked Questions About Essential Performance Requirements<\/b><\/h2>\n<h3><b>What is the difference between essential performance and basic performance?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Essential performance covers clinical functions that cross the IEC 60601-1 unacceptable-risk threshold. Basic performance is what the device delivers per manufacturer specifications, labeling, public claims, or risk controls, and standardized performance covers requirements published in national or international standards. Teams can document those distinctions in design input requirements to avoid over-declaring or under-declaring EPRs.<\/span><\/p>\n<h3><b>Does essential performance apply to in vitro diagnostic devices or standalone software?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">IEC 60601-1 does not apply to in vitro diagnostic (IVD) devices or<\/span><a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/software-as-a-medical-device-revolutionizing-healthcare\/\"> <span style=\"font-weight: 400;\">standalone software<\/span><\/a><span style=\"font-weight: 400;\">. IEC 61010-1, its sister standard, is a safety-only standard that doesn&#8217;t address essential performance. Embedded software that controls or monitors a device, such as a heart-lung machine&#8217;s pump control, can still implement essential performance characteristics and needs linked test cases.<\/span><\/p>\n<h3><b>Can a manufacturer treat all functions as essential performance for immunity testing?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Yes. For immunity testing, manufacturers may either identify essential performance with guidance in Annex GGG or consider all functions essential under IEC 60601-1-2. The current edition also requires notifying end users about any expected loss of performance, even when the degradation doesn&#8217;t affect basic safety or essential performance.<\/span><\/p>\n<p>This article was authored by\u00a0<a href=\"https:\/\/www.jamasoftware.com\/blog\/author\/trish\/\" target=\"_blank\" rel=\"noopener\">Tom Rish<\/a> and published on August 7, 2026.<\/p>\n<\/div><\/section><\/div><section  class='av_textblock_section av-kt272dwm-d42d3d376d99045ff6cfafa99fec44da '  ><div class='avia_textblock' ><div class=\"flex_column_table av-equal-height-column-flextable\"><div class=\"flex_column av_one_half flex_column_div first previous\">\n\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/\" class=\"\"><div class=\"arrow\"><a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/\" class=\"\">PREVIOUS<\/a>\n\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/legacy\/requirements-management-guide\/product-development-terms-and-definitions\/\" class=\"\"><span class=\"title\">Product Development Terms and Definitions<\/span><\/a><\/div>\n\t\t\t<\/div><\/div><div id=\"form\" class=\"cta-background flex_column_table av-equal-height-column-flextable\"><div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-reverse'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m4auxxrv-ed813687835a92784865e29ca937fa69\">\n.flex_column.av-m4auxxrv-ed813687835a92784865e29ca937fa69{\nwidth:59.2%;\nborder-radius:8px 8px 8px 8px;\npadding:20px 20px 20px 20px;\nbackground-color:#f8fbff;\nbackground:linear-gradient( to bottom, #f8fbff, #fafbfd );\n}\n<\/style>\n<div  class='flex_column av-m4auxxrv-ed813687835a92784865e29ca937fa69 av_three_fifth  column-form white-bkg first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba\">\n#top .av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba{\npadding-bottom:10px;\ncolor:#000e78;\n}\nbody .av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .special-heading-inner-border{\nborder-color:#000e78;\n}\n.av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba av-special-heading-h3 custom-color-heading blockquote modern-quote modern-centered'><h3 class='av-special-heading-tag '  >Book a Demo<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-m4av0qkv-a50042b97728bc28c371ad31790bf0af '  ><div class='avia_textblock green-btn' ><style>\n#top .column-form.white-bkg #mktoForm_3182.mktoForm {width:100% !important;}#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow {width:100%;display:block;}#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+1), #top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+2) { width: 49% !important; margin: 0 1% 0 0; width: 49% !important;}@media (max-width: 480px) {#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+1), #top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+2){width:100% !important;}}<\/style>\n<form id=\"mktoForm_3182\"><\/form>\n<p><script>\nMktoForms2.loadForm(\"\/\/go.jamasoftware.com\", \"078-EIF-407\", 3182);\nMktoForms2.whenReady(function (form){\nvar redirectTimeMs = 4000;  \n\/*Add an onSuccess handler*\/ \nform.onSuccess(function(values, followUpUrl){\nvar thankYouURL = followUpUrl+  \"?FirstName=\" + encodeURIComponent(values.FirstName) +  \"&LastName=\" + encodeURIComponent(values.LastName)+  \"&Email=\" + encodeURIComponent(values.Email);console.log(thankYouURL);\ndocument.location.href = thankYouURL;\nreturn false;\n});\n});\n<\/script><\/p>\n<\/div><\/section><\/div><\/div><!--close flex column wrapper. 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