{"id":39136,"date":"2020-08-18T03:00:12","date_gmt":"2020-08-18T10:00:12","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=39136"},"modified":"2023-01-12T16:50:24","modified_gmt":"2023-01-13T00:50:24","slug":"design-control-and-risk-management-in-medical-device-development","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/","title":{"rendered":"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-39138\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\" alt=\"Documents-Based Design Control\" width=\"1024\" height=\"512\" \/><\/p>\n<p><span data-contrast=\"none\">Medical device companies are on the cutting-edge of advancing health care. Along with facing relentless pressures to innovate and release quality products, they also must comply with regulations and standards to remain competitive.<\/span><span data-contrast=\"none\">\u00a0And a big part of that is design control and risk management in medical device development.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">We recently held a webinar specifically designed for product and <a href=\"https:\/\/www.jamasoftware.com\/solutions\/medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\">engineering teams building medical devices<\/a>, demonstrating how to move beyond the frustrations of disconnected, document-based requirement systems, streamlining your design and development and <a href=\"https:\/\/www.jamasoftware.com\/solutions\/risk-management\/\" target=\"_blank\" rel=\"noopener noreferrer\">risk management processes<\/a> while maintaining compliance with applicable regulations and standards.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Below you\u2019ll find an abbreviated transcript and the webinar recording.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><br \/>\n<script src=\"https:\/\/fast.wistia.com\/embed\/medias\/zj6of54f4l.jsonp\" async><\/script><script src=\"https:\/\/fast.wistia.com\/assets\/external\/E-v1.js\" async><\/script><\/p>\n<div class=\"wistia_responsive_padding\" style=\"padding: 56.25% 0 0 0; position: relative;\">\n<div class=\"wistia_responsive_wrapper\" style=\"height: 100%; left: 0; position: absolute; top: 0; width: 100%;\">\n<div class=\"wistia_embed wistia_async_zj6of54f4l videoFoam=true\" style=\"height: 100%; position: relative; width: 100%;\">\n<div class=\"wistia_swatch\" style=\"height: 100%; left: 0; opacity: 0; overflow: hidden; position: absolute; top: 0; transition: opacity 200ms; width: 100%;\"><img decoding=\"async\" style=\"filter: blur(5px); height: 100%; object-fit: contain; width: 100%;\" src=\"https:\/\/fast.wistia.com\/embed\/medias\/zj6of54f4l\/swatch\" alt=\"\" aria-hidden=\"true\" \/><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<h2><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\"> Move from\u00a0a Documents-Based Design Control and Risk Management in Medical Device\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">If\u00a0<\/span><span data-contrast=\"auto\">we consider two aspects of your work, the first being the processes and tools that define your methodology and support your work, and the second being the documentation generated to show compliance with applicable regulations and standards, what tends to drive your team?<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Although<\/span><span data-contrast=\"auto\">\u00a0it is true that both are necessary, you may find that one carries more weight than the other.\u00a0<\/span><span data-contrast=\"auto\">For\u00a0<\/span><span data-contrast=\"auto\">many medical device manufacturers, the answer has been to prioritize the documentation needs of the quality system, especially when considering regulated design control and risk management activities.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This\u00a0<\/span><span data-contrast=\"auto\">is understandable given that the documentation serves as the evidence that&#8217;s needed to get a product cleared and into the market. But as we&#8217;ll see, there are challenges teams face when documentation starts to tip the scale. Our assertion here at Jama<\/span><span data-contrast=\"auto\">\u00a0Software<\/span><span data-contrast=\"auto\">\u00a0is that having to prioritize the documentation needs over the product definition and development process and tools is\u00a0<\/span><span data-contrast=\"auto\">unnecessary<\/span><span data-contrast=\"auto\">. In fact, many times what feels like a prioritization of the documents over all else, is really just a symptom of using documentation tools like Word or Excel to manage product development activities.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">What tends to happen is the quality management system requires specific documents as evidence of proper design and development activities and to show alignment with regulatory requirements. And working backwards from those quality needs results in the use of documentation tools to support the product development life cycle.\u00a0<\/span><span data-contrast=\"auto\">T<\/span><span data-contrast=\"auto\">his may work for a while, but often does not scale.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">T<\/span><span data-contrast=\"auto\">he problem here is that the opportunity to improve processes and to increase efficiency and quality is not found in the documentation improvements. There isn&#8217;t a better Word template or an Excel macro that can help. The opportunities to improve are in the product development processes and tools. And this is where teams gained value.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">The Challenge Medical Device Development Teams Face\u00a0<\/span><\/b><b><span data-contrast=\"auto\">in Design Control\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">The\u00a0<\/span><span data-contrast=\"auto\">challenge, as we see it, is that teams are trying to balance the needs of meeting design control regulatory requirements with how they desire to work. And I call it specifically this idea of how teams desire to do work, because our customers are, more often than not, looking to modernize and see a lot of opportunities in new solutions and becoming more collaborative, really improving how they work.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Design control and risk management activities and the resulting required artifacts are, many times, supported by existing document-centric processes and tools. And although they are difficult to work with, sometimes the confidence and the comfort in having them and not changing, outweighs the benefits of modernizing through supporting tools and introducing change. However, though, we would argue that this comfort and confidence is really in perception only. Behind that perception is the reality of teams struggling with the need to align to market and user needs, deliver quickly to market, and build efficiencies into how they work together. All th<\/span><span data-contrast=\"auto\">e\u00a0<\/span><span data-contrast=\"auto\">while working to produce and maintain the necessary design control and risk related artifacts.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The<\/span><span data-contrast=\"auto\">\u00a0issue is that how teams work, and the documentation needs\u00a0<\/span><span data-contrast=\"auto\">are<\/span><span data-contrast=\"auto\">\u00a0being at odds with one another. When, in fact, that doesn&#8217;t have to be the case. Beyond team members simply struggling to keep up with the documentation needs and create the trace matrix, there is real risk to quality and gaining clearance, especially as product complexity only increases. And while it may seem that the documents that go into submission, as long as they are polished in the end, should continue to be the focus, even more so, as the docs and spreadsheets need to manage more information. There is clearly a tipping point.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">At some point, the ineffective and inefficient use of tools to manage everything becomes a\u00a0<\/span><span data-contrast=\"auto\">risk in itself<\/span><span data-contrast=\"auto\">. Things get missed, precious time gets consumed, rework overwhelms innovation. Now, this is not to say that compliance related design control and risk documentation is not important. It definitely is important. Especially considering the regulations and requirements behind them. The intention here is not to suggest that the documentation is not significant. It&#8217;s actually\u2026we suggest that because of the significance, a keen focus on the work and the product development approaches from where these materials are generated, will increase the confidence in the content in those materials, while, at the same time, opening the organization up to opportunities for efficiency and process improvements.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">The Complexity of Design Control of Medical Device is Real\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">To take just a couple of examples, here you can see that the median number of years to reach the initial 510(k) clearance has increased from three and a half years to just over five years. And that&#8217;s between 2007 and 2013. And if that&#8217;s not sign enough of increasing complexity, look to the increase in the number of pages in a 510(k) submission from 1983 to 2017. That is over a 2,000 percent increase. And consider this, that chart starts at 1983, and Microsoft Word, which many of the customers I work with are transitioning away from, was launched in 1983. And that&#8217;s when the 510(k) averaged about 50 pages.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Y<\/span><span data-contrast=\"auto\">ou may consider increasing complexity against productivity, or metrics around time to market, or even your organizations willingness to change and to adopt new tools. These might be places you find where the challenge manifests for your teams.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Balancing the\u00a0<\/span><\/b><b><span data-contrast=\"auto\">Requirements<\/span><\/b><b><span data-contrast=\"auto\">\u00a0of the Quality System with Your Approach<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">The shift,\u00a0<\/span><span data-contrast=\"auto\">we see it, is not to eliminate or downplay the importance of the documentation supporting your regulated, auditable, design control and risk management activities. We see the shift as balancing the requirements of the quality system with your approach to product development. And this balance is found by constructing an approach to how you work, so that the needs of the quality system and the required documentation are\u00a0<\/span><span data-contrast=\"auto\">actually byproducts<\/span><span data-contrast=\"auto\">\u00a0of your work, not in themselves defining, or the constraining factor.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">By shifting or balancing, really, the focus toward your product development approach, we suggest that organizations can then look to improve their processes and modernize their tools without negatively impacting or neglecting the regulatory requirements driving documentation today. And the key to making the shift, one that balances product development and documentation needs, is Systems Thinking. And the shift and implementation of Systems Thinking, with it manufacturers can really begin to take advantage of systems engineering principles for developing complex products and find efficiencies in how they work, both cross functionally and in the solutions and tools they use to support their work.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<hr \/>\n<h5 style=\"text-align: center;\"><span data-contrast=\"auto\">Watch the full webinar recording to learn more about implementing a design control and risk management approach informed by System Thinking<\/span><span data-contrast=\"auto\">, how Jama Connect for Medical Device Development can help, and more.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h5>\n<p style=\"text-align: center;\"><a style=\"background-color: #d5502a; border-radius: 80px; 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\/webinar\/move-from-documents-based-design-control-and-risk-management?utm_campaign=cta+blog\">WATCH NOW<\/a><\/p>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"39136\"\/>","protected":false},"excerpt":{"rendered":"<p>In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system. <\/p>\n","protected":false},"author":4,"featured_media":47037,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[488],"tags":[10,513,514],"industry":[574],"class_list":["post-39136","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-risk-management","tag-collaboration","tag-design-control","tag-document","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>Design Control and Risk Management in Medical Devices - Jama Software<\/title>\n<meta name=\"description\" content=\"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.\" \/>\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\/08\/18\/design-control-and-risk-management-in-medical-device-development\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device\" \/>\n<meta property=\"og:description\" content=\"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/\" \/>\n<meta property=\"og:site_name\" content=\"Jama Software\" \/>\n<meta property=\"article:published_time\" content=\"2020-08-18T10:00:12+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-13T00:50:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jama Software\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jama Software\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 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\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/\"},\"author\":{\"name\":\"Jama Software\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/59a942565a528aa5f56b240c9342fc7f\"},\"headline\":\"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device\",\"datePublished\":\"2020-08-18T10:00:12+00:00\",\"dateModified\":\"2023-01-13T00:50:24+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/\"},\"wordCount\":1247,\"image\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2020\\\/08\\\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\",\"keywords\":[\"collaboration\",\"design control\",\"document\"],\"articleSection\":[\"Risk Management\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/\",\"name\":\"Design Control and Risk Management in Medical Devices - Jama Software\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2020\\\/08\\\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\",\"datePublished\":\"2020-08-18T10:00:12+00:00\",\"dateModified\":\"2023-01-13T00:50:24+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/59a942565a528aa5f56b240c9342fc7f\"},\"description\":\"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2020\\\/08\\\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\",\"contentUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2020\\\/08\\\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg\",\"width\":1024,\"height\":512},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2020\\\/08\\\/18\\\/design-control-and-risk-management-in-medical-device-development\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.jamasoftware.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device\"}]},{\"@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\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/59a942565a528aa5f56b240c9342fc7f\",\"name\":\"Jama Software\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g\",\"caption\":\"Jama Software\"},\"description\":\"Subject matter experts from Jama Software provide guidance and best practices on requirements management, test management, compliance and regulation, risk management, and complex product and software development.\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/author\\\/jama-software\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Design Control and Risk Management in Medical Devices - Jama Software","description":"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.","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\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/","og_locale":"en_US","og_type":"article","og_title":"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device","og_description":"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.","og_url":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/","og_site_name":"Jama Software","article_published_time":"2020-08-18T10:00:12+00:00","article_modified_time":"2023-01-13T00:50:24+00:00","og_image":[{"width":1024,"height":512,"url":"https:\/\/www.jamasoftware.com\/legacy\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg","type":"image\/jpeg"}],"author":"Jama Software","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Jama Software","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#article","isPartOf":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/"},"author":{"name":"Jama Software","@id":"https:\/\/www.jamasoftware.com\/#\/schema\/person\/59a942565a528aa5f56b240c9342fc7f"},"headline":"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device","datePublished":"2020-08-18T10:00:12+00:00","dateModified":"2023-01-13T00:50:24+00:00","mainEntityOfPage":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/"},"wordCount":1247,"image":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#primaryimage"},"thumbnailUrl":"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg","keywords":["collaboration","design control","document"],"articleSection":["Risk Management"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/","url":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/","name":"Design Control and Risk Management in Medical Devices - Jama Software","isPartOf":{"@id":"https:\/\/www.jamasoftware.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#primaryimage"},"image":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#primaryimage"},"thumbnailUrl":"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg","datePublished":"2020-08-18T10:00:12+00:00","dateModified":"2023-01-13T00:50:24+00:00","author":{"@id":"https:\/\/www.jamasoftware.com\/#\/schema\/person\/59a942565a528aa5f56b240c9342fc7f"},"description":"In this blog post, we explain how to improve design control and risk management in medical device development by moving away from a document-based system.","breadcrumb":{"@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#primaryimage","url":"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg","contentUrl":"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-13_Webinar-Recap-MoveFromDocumentsBasedWebinar-1024x512-1.jpg","width":1024,"height":512},{"@type":"BreadcrumbList","@id":"https:\/\/www.jamasoftware.com\/blog\/2020\/08\/18\/design-control-and-risk-management-in-medical-device-development\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.jamasoftware.com\/"},{"@type":"ListItem","position":2,"name":"Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device"}]},{"@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"},{"@type":"Person","@id":"https:\/\/www.jamasoftware.com\/#\/schema\/person\/59a942565a528aa5f56b240c9342fc7f","name":"Jama Software","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","caption":"Jama Software"},"description":"Subject matter experts from Jama Software provide guidance and best practices on requirements management, test management, compliance and regulation, risk management, and complex product and software development.","url":"https:\/\/www.jamasoftware.com\/blog\/author\/jama-software\/"}]}},"_links":{"self":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts\/39136","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/comments?post=39136"}],"version-history":[{"count":0,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts\/39136\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media\/47037"}],"wp:attachment":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media?parent=39136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/categories?post=39136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/tags?post=39136"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/industry?post=39136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}