{"id":82935,"date":"2025-05-14T15:16:51","date_gmt":"2025-05-14T22:16:51","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=resource-page&#038;p=82935"},"modified":"2025-05-28T16:02:41","modified_gmt":"2025-05-28T23:02:41","slug":"the-evolution-of-fda-design-controls-21-cfr-820-30-and-how-jama-software-supports-compliance","status":"publish","type":"resource-page","link":"https:\/\/www.jamasoftware.com\/legacy\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/","title":{"rendered":"The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software\u00ae Supports Compliance"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-1xk07xh-bbbec7a78c99a3bc73edbd2023502169 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  avia-builder-el-no-sibling  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-82935'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 sc-av_two_fifth av-equal-height-column-flextable'><div  class='flex_column av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 av_two_fifth  avia-builder-el-1  el_before_av_three_fifth  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle  '     ><\/div><div class='av-flex-placeholder'><\/div><div  class='flex_column av-1dfyz5x-54808b3f45749ff6a22951230de9ef19 av_three_fifth  avia-builder-el-3  el_after_av_two_fifth  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-middle  '     ><p><br \/>\n<\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ljz2oc54-f4c32aef36da49fd259c264837168768\">\n#top .hr.hr-invisible.av-ljz2oc54-f4c32aef36da49fd259c264837168768{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-ljz2oc54-f4c32aef36da49fd259c264837168768 hr-invisible  avia-builder-el-6  el_after_av_three_fifth  el_before_av_one_full '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div  class='flex_column av-wga891-b5f28f812c6cab24bcc18bf3ef4b1f27 av_one_full  avia-builder-el-7  el_after_av_hr  avia-builder-el-last  first flex_column_div  '     ><section  class='av_textblock_section av-ljz0yqe6-4e9d14322421778c88a0b363f0043402 '  ><div class='avia_textblock' ><p>Design controls are a cornerstone of medical device quality management, providing a structured framework to ensure medical devices meet safety, efficacy, and regulatory standards. The overarching goal of design controls is to integrate quality into the design and development process.<\/p>\n<p>In this eBook, we cover the evolution of FDA Design Controls (21 CFR 820.30), and take a look into:<\/p>\n<ul>\n<li>The 10 sections of FDA design controls<\/li>\n<li>Upcoming factors impacting design controls<\/li>\n<li>Aligning FDA\u2019s new quality management system regulation (QMSR) with ISO 13485<\/li>\n<li>How Jama Software can help<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/main><!-- close content main element --><\/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-82935'><div class='entry-content-wrapper clearfix'>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"82935\"\/>","protected":false},"excerpt":{"rendered":"","protected":false},"author":141,"featured_media":82937,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"resource_type":[887],"resource_industry":[901],"primary_topic":[924,913,920],"primary_challenge":[932],"competitors":[],"partners":[],"secondary_topic":[],"secondary_challenge":[],"class_list":["post-82935","resource-page","type-resource-page","status-publish","has-post-thumbnail","hentry","resource_type-whitepaper","resource_industry-medical-devices-life-science","primary_topic-change-management","primary_topic-compliance-regulation","primary_topic-traceability","primary_challenge-regulatory-compliance"],"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>FDA Design Controls (21 CFR 820.30)<\/title>\n<meta name=\"description\" content=\"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device &amp; life sciences development.\" \/>\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\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software\u00ae Supports Compliance\" \/>\n<meta property=\"og:description\" content=\"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device &amp; life sciences development.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/\" \/>\n<meta property=\"og:site_name\" content=\"Jama Software\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-28T23:02:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2025\/05\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png\" \/>\n\t<meta property=\"og:image:width\" content=\"500\" \/>\n\t<meta property=\"og:image:height\" content=\"272\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/\",\"name\":\"FDA Design Controls (21 CFR 820.30)\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2025\\\/05\\\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png\",\"datePublished\":\"2025-05-14T22:16:51+00:00\",\"dateModified\":\"2025-05-28T23:02:41+00:00\",\"description\":\"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device & life sciences development.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2025\\\/05\\\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png\",\"contentUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2025\\\/05\\\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png\",\"width\":500,\"height\":272,\"caption\":\"Medical researcher working in a lab and checking off compliance checklist.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/resource\\\/whitepaper\\\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.jamasoftware.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software\u00ae Supports Compliance\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#website\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/\",\"name\":\"Jama Software\",\"description\":\"Jama Connect\u00ae #1 in Requirements Management\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.jamasoftware.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA Design Controls (21 CFR 820.30)","description":"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device & life sciences development.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/","og_locale":"en_US","og_type":"article","og_title":"The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software\u00ae Supports Compliance","og_description":"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device & life sciences development.","og_url":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/","og_site_name":"Jama Software","article_modified_time":"2025-05-28T23:02:41+00:00","og_image":[{"width":500,"height":272,"url":"https:\/\/www.jamasoftware.com\/legacy\/media\/2025\/05\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/","url":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/","name":"FDA Design Controls (21 CFR 820.30)","isPartOf":{"@id":"https:\/\/www.jamasoftware.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/#primaryimage"},"image":{"@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/#primaryimage"},"thumbnailUrl":"https:\/\/www.jamasoftware.com\/media\/2025\/05\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png","datePublished":"2025-05-14T22:16:51+00:00","dateModified":"2025-05-28T23:02:41+00:00","description":"Learn about the evolution of FDA Design Controls (21 CFR 820.30) and how it impacts medical device & life sciences development.","breadcrumb":{"@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/#primaryimage","url":"https:\/\/www.jamasoftware.com\/media\/2025\/05\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png","contentUrl":"https:\/\/www.jamasoftware.com\/media\/2025\/05\/21-CFR-design-controls-whitepaper-thumbnail-500x272.jpg.png","width":500,"height":272,"caption":"Medical researcher working in a lab and checking off compliance checklist."},{"@type":"BreadcrumbList","@id":"https:\/\/www.jamasoftware.com\/resource\/whitepaper\/the-evolution-of-fda-design-controls-21-cfr-82030-and-how-jama-software-supports-compliance\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.jamasoftware.com\/"},{"@type":"ListItem","position":2,"name":"The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software\u00ae Supports Compliance"}]},{"@type":"WebSite","@id":"https:\/\/www.jamasoftware.com\/#website","url":"https:\/\/www.jamasoftware.com\/","name":"Jama Software","description":"Jama Connect\u00ae #1 in Requirements Management","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.jamasoftware.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/resource-page\/82935","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/resource-page"}],"about":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/types\/resource-page"}],"author":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/users\/141"}],"version-history":[{"count":0,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/resource-page\/82935\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media\/82937"}],"wp:attachment":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media?parent=82935"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/resource_type?post=82935"},{"taxonomy":"resource_industry","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/resource_industry?post=82935"},{"taxonomy":"primary_topic","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/primary_topic?post=82935"},{"taxonomy":"primary_challenge","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/primary_challenge?post=82935"},{"taxonomy":"competitors","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/competitors?post=82935"},{"taxonomy":"partners","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/partners?post=82935"},{"taxonomy":"secondary_topic","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/secondary_topic?post=82935"},{"taxonomy":"secondary_challenge","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/secondary_challenge?post=82935"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}