{"id":38656,"date":"2020-06-18T14:30:56","date_gmt":"2020-06-18T21:30:56","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=38656"},"modified":"2023-01-12T16:50:32","modified_gmt":"2023-01-13T00:50:32","slug":"part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2020\/06\/18\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\/","title":{"rendered":"Part IV: Connecting\u202fDesign Controls, Including\u202fDesign Inputs, Design Outputs and Verifications\u202f"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignnone size-full wp-image-38665\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/2020-06-18_PartFour_ConnectingDesignControls_Inputs_OutputsJamaConnectForMedDevices_1024x512.jpg\" alt=\"\" width=\"1024\" height=\"512\" \/><\/p>\n<p>In the previous blog of this series, we talked about <a href=\"https:\/\/www.jamasoftware.com\/blog\/part-3-design-inputs-in-jama-connect-for-medical-device-development\/\" target=\"_blank\" rel=\"noopener noreferrer\">the application of systems engineering principles to the design inputs process<\/a>. In this post, we explore how the <a href=\"https:\/\/www.jamasoftware.com\/solutions\/medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\">Jama Connect\u2122 for Medical Device Development<\/a> procedure guide describes connecting design inputs with subsequent processes: Design Outputs and Verifications.\u202fBy supporting these processes in a single system and ensuring traceability we can build confidence in the conformance to design inputs and the proper definition of verification activities.<\/p>\n<p>The Jama Connect for Medical Device Development solution focuses on two key aspects from the\u202fDesign Output requirements\u202fdefined by\u202f21 CFR 820.30\u202fand\u202fISO 13485:2016 section 7.3.4.\u202fDesign outputs:<\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">must \u202freference acceptance criteria, ensuring they are essential to proper functioning,<\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\">are evaluated for\u202fconformance to design input requirements<\/li>\n<\/ul>\n<h4><strong>Design outputs will vary based on the product, technology, discipline and applicable standards.<\/strong><\/h4>\n<p>The regulation and standards are not specific about the content of the design outputs themselves. The significant activity then from a design control perspective is ensuring a trace to design inputs and visibility into the verification of those design inputs.<\/p>\n<p>When defining design inputs (i.e., system and subsystem requirements), the guide recommends\u202fstating\u202facceptance criteria directly in the\u202frequirement items. In fact, the system and subsystem requirements\u202fare configured capture\u202fit out of the box. Below is a sample System Requirement using the out of the box system requirement configuration.<\/p>\n<p><img decoding=\"async\" class=\"alignnone wp-image-38679\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/Waterproof-Jama-Software-2020-06-17-14-47-14.jpg\" alt=\"\" width=\"983\" height=\"245\" \/><\/p>\n<p><span data-contrast=\"auto\">Verification items, traced to design inputs,\u202fshould be\u202fdefined based on the acceptance criteria. Similarly, design output items (e.g., architecture diagrams) are traced to design inputs and refer to requirement details and acceptance criteria for\u202fdesign and development.\u202f<\/span><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u202f<\/span><span data-contrast=\"auto\">For some disciplines,\u202flike\u202fSoftware, Jama Connect may contain\u202fmore detailed levels of abstraction\u202fand, therefore, may have items that tie directly into development tools. For other disciplines, Jama Connect may contain very basic information\u202fand\u202fpointers to\u202fother\u202fsystems\u202fmanaging design outputs\u202fdetails,\u202flike parts\u202ffor manufacturing.<\/span><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u202f<\/span><span data-contrast=\"auto\">The Relationship Rule below provided with the Jama Connect for Medical Device Development out of the box configuration shows how design outputs (in orange) and verifications (in green) trace directly to design inputs (in blue).<\/span><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true}\">\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"alignnone wp-image-38657\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/Admin-Jama-Software-2020-06-16-21-17-57-1.jpg\" alt=\"\" width=\"598\" height=\"146\" \/><\/p>\n<p><span data-contrast=\"auto\">Using this approach, the design input serves as the\u202fpoint\u202fconnecting design outputs and verifications. Design outputs contain or point to evidence of the implementation of the design input, while verifications provide evidence\u202fthrough testing\u202fthat the intent of the design input is met. Both design outputs and verifications reference the acceptance criteria captured in the design input\u202fduring their definition and by nature of the trace.<\/span><span data-contrast=\"auto\">\u202f<\/span><\/p>\n<p>&nbsp;<\/p>\n<h4><span data-contrast=\"auto\"><strong><span class=\"TextRun MacChromeBold BCX0 SCXW88172800\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW88172800\" data-ccp-charstyle=\"normaltextrun\">C<\/span><\/span><span class=\"TextRun MacChromeBold BCX0 SCXW88172800\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW88172800\" data-ccp-charstyle=\"normaltextrun\">onnecting design inputs with design outputs and verifications.<\/span><\/span><\/strong><br \/>\n<\/span><\/h4>\n<p><span data-contrast=\"auto\">The trace established by connecting design inputs with design outputs and verifications is visible in Jama\u202f<\/span><span data-contrast=\"auto\">Connect\u2019s<\/span><span data-contrast=\"auto\">\u202fTrace View. The sample of a Trace View below shows a requirement\u202fwith two related items downstream, a verification and design output. The verification in this\u202fexample shows &#8220;Passed\u201d, which indicates the intent of the requirement was met via implementation of the related design output.<\/span><span data-contrast=\"auto\">\u202f<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true}\">\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"alignnone wp-image-38661\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/Performance-Trace-View-Jama-Software-2020-06-16-21-15-34-1.jpg\" alt=\"\" width=\"726\" height=\"163\" \/><\/p>\n<p>By capturing\u202facceptance\u202fcriteria during the Design Input process, exposing that information to related downstream processes, and\u202fusing\u202ftrace\u202fas a part of normal\u202fproduct\u202fdefinition\u202factivities, manufacturers gain visibility into\u202fthe conformity of design outputs and\u202fbuild confidence in\u202ftheir verification activities and results. As seen in the Trace View above, relating information in Jama Connect is key to understanding coverage\u202fand\u202fverification.<\/p>\n<p>In the next blog in this series, we&#8217;ll explore making further use of the trace, beyond simply matrix generation.<\/p>\n<p><strong>Haven&#8217;t read the earlier blogs in the series? You can catch up here.<\/strong><\/p>\n<p><a href=\"https:\/\/www.jamasoftware.com\/blog\/part-one-jama-connect-for-medical-device-development-explained\/\">Part One: Jama Connect\u2122 for Medical Device Development Explained<\/a><\/p>\n<p><a href=\"https:\/\/www.jamasoftware.com\/blog\/part-ii-solution-components-of-jama-connect-for-medical-device-development\/\">Part II: Solution Components of Jama Connect for Medical Device Development<\/a><\/p>\n<p><a href=\"https:\/\/www.jamasoftware.com\/blog\/part-3-design-inputs-in-jama-connect-for-medical-device-development\/\">Part III:\u202fDesign Inputs\u202fin\u202fJama Connect for Medical Device Development\u202f<\/a><\/p>\n<h5><\/h5>\n<p>&nbsp;<\/p>\n<h5 style=\"text-align: center;\">Watch a demo to see Jama Connect Medical Device Development Solution features in action and understand how teams use it to support their development process.<\/h5>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\"><a style=\"background-color: #d5502a; border-radius: 30px; color: #ffffff; display: inline-block; font-family: sans-serif; font-size: 13px; font-weight: bold; line-height: 40px; text-align: center; text-decoration: none; width: 200px; -webkit-text-size-adjust: none;\" href=\"https:\/\/resources.jamasoftware.com\/demo\/jama-connect-medical-devices\" target=\"_blank\" rel=\"noopener\">WATCH NOW<\/a><!-- [if mso]>\n<\/center>\n<\/v:roundrect><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\"><\/span>\n<![endif]--><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the previous blog of this series, we talked about the application of systems engineering principles to the design inputs process. In this post, we explore how the Jama Connect\u2122 for Medical Device Development procedure guide describes connecting design inputs with subsequent processes: Design Outputs and Verifications.\u202fBy supporting these processes in a single system and [&hellip;]<\/p>\n","protected":false},"author":80,"featured_media":47625,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72],"tags":[43,41,417],"industry":[574],"class_list":["post-38656","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-product-development-and-management","tag-medical-device","tag-medical-device-development","tag-medical-device-requirements","industry-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Connecting\u202fDesign Controls, Including Design Inputs, Design Outputs and Verifications\u202f - Jama Software<\/title>\n<meta name=\"description\" content=\"The Jama Software Medical Device Development solution helps you manage requirements for 820.30, and connect design inputs with design outputs and verifications.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.jamasoftware.com\/blog\/2020\/06\/18\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Part IV: Connecting\u202fDesign Controls, Including\u202fDesign Inputs, Design Outputs and Verifications\u202f\" \/>\n<meta property=\"og:description\" content=\"The Jama Software Medical Device Development solution helps you manage requirements for 820.30, and connect design inputs with design outputs and verifications.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.jamasoftware.com\/blog\/2020\/06\/18\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\/\" \/>\n<meta property=\"og:site_name\" content=\"Jama Software\" \/>\n<meta property=\"article:published_time\" content=\"2020-06-18T21:30:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-13T00:50:32+00:00\" \/>\n<meta name=\"author\" content=\"Zeb Geary\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Zeb Geary\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/06\\\/18\\\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/06\\\/18\\\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\\\/\"},\"author\":{\"name\":\"Zeb Geary\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/401046f58d1d3306c1dac1484f69c640\"},\"headline\":\"Part IV: Connecting\u202fDesign Controls, Including\u202fDesign Inputs, Design Outputs and Verifications\u202f\",\"datePublished\":\"2020-06-18T21:30:56+00:00\",\"dateModified\":\"2023-01-13T00:50:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/06\\\/18\\\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\\\/\"},\"wordCount\":657,\"image\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/06\\\/18\\\/part-iv-connecting-design-controls-including-design-inputs-design-outputs-and-verifications\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2020\\\/06\\\/2020-06-18_PartFour_ConnectingDesignControls_Inputs_OutputsJamaConnectForMedDevices_1024x512.jpg\",\"keywords\":[\"medical device\",\"medical device development\",\"medical device requirements\"],\"articleSection\":[\"Product Development &amp; 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