{"id":39329,"date":"2020-08-25T03:00:10","date_gmt":"2020-08-25T10:00:10","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=39329"},"modified":"2023-01-12T16:50:23","modified_gmt":"2023-01-13T00:50:23","slug":"navigating-medical-device-compliance-6-key-tips","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2020\/08\/25\/navigating-medical-device-compliance-6-key-tips\/","title":{"rendered":"Navigating Medical Device Compliance: 6 Key Tips"},"content":{"rendered":"<p><span data-contrast=\"auto\"><img decoding=\"async\" class=\"aligncenter size-full wp-image-39332\" src=\"https:\/\/www.jamasoftware.com\/media\/2020\/08\/2020-08-25_NavigatingMedicalDeviceCompliance6Steps_1024x512.jpg\" alt=\"Medical Device Compliance\" width=\"1024\" height=\"512\" \/>Medical device development is inherently complex, with numerous ever-evolving regulatory statutes to comply with and especially high stakes for ensuring the ultimate safety of the product<\/span><span data-contrast=\"auto\">. In fact:\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Arial, Arial_MSFontService, sans-serif\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Medical device recalls\u00a0<\/span><a href=\"https:\/\/www.mddionline.com\/regulatory-and-compliance\/medical-device-recalls-were-way-2019\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">rose 50% in 2019<\/span><\/a><span data-contrast=\"auto\">, demonstrating the growing complexity of devices and their points of failure, as well as active regulatory enforcement.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Arial, Arial_MSFontService, sans-serif\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Class I recalls, the most serious type, having a \u201creasonable probability\u201d of the affected device causing harm,\u00a0<\/span><a href=\"https:\/\/www.qualio.com\/blog\/medical-device-recall-statistics\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">have surged at an even hi<\/span><span data-contrast=\"none\">g<\/span><span data-contrast=\"none\">her rate<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Arial, Arial_MSFontService, sans-serif\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Devices like\u00a0<\/span><a href=\"https:\/\/www.webmd.com\/heart\/news\/20170905\/recall-abbott-pacemakers-for-hacking-threat\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">software-driven pacemakers<\/span><\/a><span data-contrast=\"auto\">\u00a0illustrate the tradeoff between more complex hardware and more extensive risks requiring mitigation.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Indeed, the growing centrality of software to modern medical devices is a particularly notable challenge for manufacturers in this context.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Not only do software-driven devices require a particular<\/span><span data-contrast=\"auto\">\u00a0and extensive<\/span><span data-contrast=\"auto\">\u00a0approach to risk and requirements management, but they also create pressure to accelerate time to market<\/span><span data-contrast=\"auto\">\u00a0due to an increasingly competitive market.<\/span><span data-contrast=\"auto\">\u00a0New entrants into the medical device space have used software design to rapidly differentiate their products and compete with incumbents, as the FDA\u2019s 2018\u00a0<\/span><a href=\"https:\/\/www.theverge.com\/2018\/9\/13\/17855006\/apple-watch-series-4-ekg-fda-approved-vs-cleared-meaning-safe\"><span data-contrast=\"none\">Class II\u00a0<\/span><\/a><a href=\"https:\/\/www.theverge.com\/2018\/9\/13\/17855006\/apple-watch-series-4-ekg-fda-approved-vs-cleared-meaning-safe\" target=\"_blank\" rel=\"noopener noreferrer\"><i><span data-contrast=\"none\">de novo<\/span><\/i><\/a><a href=\"https:\/\/www.theverge.com\/2018\/9\/13\/17855006\/apple-watch-series-4-ekg-fda-approved-vs-cleared-meaning-safe\"><span data-contrast=\"none\">\u00a0clearance<\/span><\/a><span data-contrast=\"auto\">\u00a0for EKG-equipped Apple Watches shows.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Bringing medical devices to market quickly while preserving their quality and complying with regulations is a balancing act, albeit one that can be executed successfully with the right requirements management platform. Medical device compliance is achievable via a coherent, well-documented product lifecycle and real-time collaboration, both of which require efficient processes.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Based on our work with hundreds of medical device developers, we\u2019ve compiled this guide to navigating the complexity of medical device compliance. Let\u2019s dive into six tips for improving your development practices.<\/span><\/p>\n<h2>Tip 1: Use a Tool That\u2019s Already Aligned with Industry Standards<\/h2>\n<p><a href=\"https:\/\/resources.jamasoftware.com\/medical-device\/iso-14971-managing-risk-for-medical-device-developers-in-jama-connect\"><span data-contrast=\"none\">ISO 14971:2019<\/span><\/a><span data-contrast=\"auto\">\u00a0and ISO 13485:2016 both include detailed guidance on how to manage medical risk\u00a0<\/span><span data-contrast=\"auto\">and quality management\u00a0<\/span><span data-contrast=\"auto\">processes<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">as\u00a0<\/span><span data-contrast=\"auto\">part of the\u00a0<\/span><span data-contrast=\"auto\">product lifecycle process. However, it can be difficult to know how to even start adhering to them under an\u00a0<\/span><span data-contrast=\"auto\">requirements management (RM)\u00a0<\/span><span data-contrast=\"auto\">methodology rooted in Microsoft Word or Excel. Teams can struggle to capture and export all of the necessary data to prove end-to-end traceability and pass audits.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Instead of reinventing the wheel for standards adherence for each project, take advantage of the\u00a0<\/span><span data-contrast=\"auto\">standard<\/span><span data-contrast=\"auto\">\u00a0frameworks in a platform like Jama Connect<\/span><span data-contrast=\"auto\">\u2122<\/span><span data-contrast=\"auto\">\u00a0for Medical Device Development<\/span><span data-contrast=\"auto\">. These save precious setup time and keep development aligned with\u00a0<\/span><span data-contrast=\"auto\">key industry regulations such as\u00a0<\/span><span data-contrast=\"auto\">ISO 14971<\/span><span data-contrast=\"auto\">:2019,\u00a0<\/span><span data-contrast=\"auto\">21 CFR 820.30, and\u00a0<\/span><span data-contrast=\"auto\">ISO 13485:201<\/span><span data-contrast=\"auto\">9.\u00a0\u00a0<\/span><\/p>\n<h2>Tip 2: Migrate Away from Document-Based Workflows<\/h2>\n<p><span data-contrast=\"auto\">Medical devices take an average of three to seven years to reach market. During that time, they will require many tests that must be traced back to requirements, plus the requirements themselves will frequently change in response to stakeholder feedback. Add in the risk inherent in complicated medical device creation, and it\u2019s a recipe for trouble without a modern<\/span><span data-contrast=\"auto\">, structured<\/span><span data-contrast=\"auto\">\u00a0platform in place.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">To keep pace with the complexity of medical device development, document-based workflows must be left behind. Circulating\u00a0<\/span><span data-contrast=\"auto\">lengthy,\u00a0<\/span><span data-contrast=\"auto\">discrete documents via email doesn\u2019t scale to modern projects, nor is it the most efficient means of gathering and synthesizing feedback from remote engineering teams. A dedicated RM platform that offers a single source of truth makes medical device compliance processes much more straightforward.<\/span><\/p>\n<hr \/>\n<p><span data-contrast=\"auto\"><span style=\"color: #ff6600;\"><strong>RELATED:<\/strong> <\/span><a href=\"https:\/\/resources.jamasoftware.com\/medical-device\/selecting-a-medical-device-development-platform\/?utm_campaign=related+blog\" target=\"_blank\" rel=\"noopener noreferrer\"><em>Your Guide to Selecting a Medical Device Development Platform<\/em><\/a><\/span><\/p>\n<hr \/>\n<h2>Tip 3: Upgrade Your Approach to Traceability<\/h2>\n<p><a href=\"https:\/\/www.jamasoftware.com\/solutions\/medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">Traceability is central to medical device development<\/span><\/a><span data-contrast=\"auto\">, as it is the only systematic way to demonstrate that\u00a0<\/span><span data-contrast=\"auto\">design inputs\u00a0<\/span><span data-contrast=\"auto\">are being\u00a0<\/span><span data-contrast=\"auto\">met and verified<\/span><span data-contrast=\"auto\">\u00a0as part of the\u00a0<\/span><span data-contrast=\"auto\">design control process. Inadequate traceability can lead to\u00a0<\/span><span data-contrast=\"auto\">errors when done manually<\/span><span data-contrast=\"auto\">, also\u00a0<\/span><span data-contrast=\"auto\">mak<\/span><span data-contrast=\"auto\">ing<\/span><span data-contrast=\"auto\">\u00a0it difficult to produce\u00a0<\/span><span data-contrast=\"auto\">audit\u00a0<\/span><span data-contrast=\"auto\">documentation<\/span><span data-contrast=\"auto\">, manage change, and prove medical device compliance.\u00a0 <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Beginning in the 2010s, software became a leading cause of medical device recalls. Accordingly,<\/span><span data-contrast=\"auto\">\u00a0in order to avoid medical device recalls or worse,<\/span><span data-contrast=\"auto\">\u00a0traceability must be sufficiently advanced to:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Link high-level requirements to sub-system requirements<\/span><span data-contrast=\"auto\">\u00a0across the development lifecycle<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Provide\u00a0<\/span><span data-contrast=\"auto\">traceabililty<\/span><span data-contrast=\"auto\">\u00a0between\u00a0<\/span><span data-contrast=\"auto\">all requirements and tes<\/span><span data-contrast=\"auto\">ts<\/span><span data-contrast=\"auto\">\u00a0in one system<\/span><span data-contrast=\"auto\">, ensuring requirements are verified and validated<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Produce necessary documentation for\u00a0<\/span><span data-contrast=\"auto\">audits and\u00a0<\/span><span data-contrast=\"auto\">regulatory\u00a0<\/span><span data-contrast=\"auto\">standards<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Eliminate the need to manually rebuild traceability\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">By having an automated way to show the impact of change on requirements<\/span><span data-contrast=\"none\">\u00a0rather than a spreadsheet<\/span><span data-contrast=\"none\">,\u202fit significantly reduces the amount of\u202fmanual\u202feffort needed to\u202flook at siloed data and where\u202fchanges may be needed.\u202f<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2>Tip 4: Create a Detailed Audit Trail<\/h2>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><span data-contrast=\"auto\">Another benefit of traceability is the ability to create a detailed audit trail demonstrating why something was built the way it was, at what time, and by whom. These audit trails are required\u00a0<\/span><span data-contrast=\"auto\">for medical device\u00a0<\/span><span data-contrast=\"auto\">development but<\/span><span data-contrast=\"auto\">\u00a0can be nearly impossible to\u00a0<\/span><span data-contrast=\"auto\">produce\u00a0<\/span><span data-contrast=\"auto\">effectively\u00a0<\/span><span data-contrast=\"auto\">if done so too late in the development process or with manual tools.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Real-time reporting and baselining are necessary for<\/span><span data-contrast=\"auto\">\u00a0accurately<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">tracking\u00a0<\/span><span data-contrast=\"auto\">changes to information within a system<\/span><span data-contrast=\"auto\">. Make sure your RM platform can provide this type of \u201cliving\u201d documentation of the development process, with all changes accurately captured as they happen. Plus, look for export functionality for sending\u00a0<\/span><span data-contrast=\"auto\">data ea<\/span><span data-contrast=\"auto\">sily<\/span><span data-contrast=\"auto\">\u00a0to<\/span><span data-contrast=\"auto\">\u00a0other systems of record like a quality management system (QMS) if necessary.\u00a0\u00a0<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<h2>Tip 5: Prioritize Secure Management of ElectronicSignatures and Records<\/h2>\n<p><span data-contrast=\"auto\">T<\/span><span data-contrast=\"auto\">he\u00a0<\/span><a href=\"https:\/\/resources.jamasoftware.com\/medical-device\/jama-connect-and-fda-21-cfr-part-11\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\">FDA\u2019s 21<\/span><span data-contrast=\"none\">\u00a0<\/span><span data-contrast=\"none\">CFR Part 11<\/span><\/a><span data-contrast=\"none\">\u00a0defines\u00a0<\/span><span data-contrast=\"none\">criteria for how electronic signatures and records\u00a0<\/span><span data-contrast=\"none\">can be used as equivalent to paper records.\u00a0\u00a0<\/span><span data-contrast=\"auto\">In order t<\/span><span data-contrast=\"auto\">o meet this regulation\u2019s very high bar for\u00a0<\/span><span data-contrast=\"auto\">proof of\u00a0<\/span><span data-contrast=\"auto\">electronic record and signature compliance<\/span><span data-contrast=\"auto\">, the proper access controls and security mechanisms need to be in place, such as:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"3\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Authentication of users via unique usernames and passwords<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"3\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Limitations on who has the authority to create an electronic signature<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"3\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Full details on when the signature was created, what it means, and who authorized it<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"\" data-listid=\"3\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Options for accurately and safely exporting the data in it for other systems or formats<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">In Jama Connect, we consider reviews the electronic record, which the FDA defines as \u201cany combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.\u201d Reviews in Jama Connect adhere to the requirements for closed systems and include electronic signatures and the requirements for linking between signatures and records.<\/span><\/p>\n<h2>Tip 6: Perform Risk Analysis Early and Continuously<\/h2>\n<p><span data-contrast=\"auto\">Waiting until the later stages of development to perform risk analyses will complicate medical device compliance<\/span><span data-contrast=\"auto\">\u00a0and uncertainty in the product development process<\/span><span data-contrast=\"auto\">. More specifically, it will slow down the entire project due to the need to gather documentation from multiple sources, make any necessary late-stage changes (for example, in response to missing\u00a0<\/span><span data-contrast=\"auto\">traceability between requirements and risks<\/span><span data-contrast=\"auto\">), and\u00a0<\/span><span data-contrast=\"auto\">ensure\u00a0<\/span><span data-contrast=\"auto\">test results reflect the latest\u00a0<\/span><span data-contrast=\"auto\">updates to risks.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Jama Connect allows for risk analysis aligned to industry standards\u00a0<\/span><span data-contrast=\"none\">like ISO 14971:2019<\/span><span data-contrast=\"none\">, treating risk management as an integral part of the product lifecycle process. Your organization\u00a0<\/span><span data-contrast=\"none\">can standardize and integrate your risk analysis, evaluation, and management processes in our platform to create a single source of truth for everything risk related.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<hr \/>\n<p>To see more information specific to the medical device development industry, we\u2019ve compiled a handy list of valuable resources for you!<!-- [if mso]>\n\n<v:roundrect xmlns:v=\"urn:schemas-microsoft-com:vml\" xmlns:w=\"urn:schemas-microsoft-com:office:word\" href=\"https:\/\/resources.jamasoftware.com\/medical-device\/?utm_campaign=cta+blog\" style=\"height:40px;v-text-anchor:middle;width:200px;\" arcsize=\"200%\" stroke=\"f\" fillcolor=\"#D5502A\">\n\n<w:anchorlock\/>\n\n<center>\n\n<![endif]--><\/p>\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\/medical-device\/?utm_campaign=cta+blog\" target=\"_blank\" rel=\"noopener noreferrer\">SEE MORE RESOURCES<\/a><\/p>\n<p>&nbsp;<\/p>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"39329\"\/>","protected":false},"excerpt":{"rendered":"<p>Based on our work with hundreds of medical device developers, we\u2019ve compiled this guide to navigating the complexity of medical device compliance.<\/p>\n","protected":false},"author":4,"featured_media":47589,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[846],"tags":[489,40,41],"industry":[574],"class_list":["post-39329","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-regulation","tag-developing-a-medical-device","tag-medical-device-compliance","tag-medical-device-development","industry-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - 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