{"id":13126,"date":"2026-01-08T13:06:03","date_gmt":"2026-01-08T13:06:03","guid":{"rendered":"https:\/\/amtivo.com\/us\/?post_type=resources-filter&#038;p=13126"},"modified":"2026-01-08T13:06:03","modified_gmt":"2026-01-08T13:06:03","slug":"fdas-new-quality-requirements-mean-for-us-medical-device-companies","status":"publish","type":"resources-filter","link":"https:\/\/amtivo.com\/us\/resources\/insights\/fdas-new-quality-requirements-mean-for-us-medical-device-companies\/","title":{"rendered":"What the FDA\u2019s New Quality Requirements Mean for U.S. Medical Device Companies"},"content":{"rendered":"<p><strong>Read our expert insights on responding to the FDA\u2019s regulatory update and aligning with <a href=\"https:\/\/amtivo.com\/us\/iso-certification\/iso-13485\/\">ISO 13485<\/a> by 2026.<\/strong><\/p>\r\n<p>&nbsp;<\/p>\r\n<h2>Understanding the FDA\u2019s\u00a0Requirements\u00a0and ISO 13485 Alignment<span> <\/span><\/h2>\r\n<p><span data-contrast=\"auto\">In 2024, the\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp\/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">U.S. Food and Drug Administration (FDA)<\/span><\/a><span data-contrast=\"auto\">\u00a0introduced new quality system requirements for medical devices\u2014the\u00a0most\u00a0significant\u00a0change\u00a0in over 25 years.<\/span><\/p>\r\n<p>These new requirements, called the\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp\/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked\" target=\"_blank\" rel=\"noopener\">Quality Management System Regulation (QMSR)<\/a>, replace the previous Quality System Regulation (QSR) and bring U.S. expectations in line with <a href=\"https:\/\/amtivo.com\/us\/iso-certification\/iso-13485\/\">ISO 13485:2016<\/a>, the globally recognized standard for medical device quality management.<\/p>\r\n<p>&nbsp;<\/p>\r\n<h2>The Goal?<\/h2>\r\n<p><span data-contrast=\"auto\">To simplify regulatory compliance, improve inspection efficiency, and support international market access. With the rule set to take effect in February 2026, medical device manufacturers should begin preparing their systems,\u00a0teams\u00a0and documentation now.<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<h2>Why the FDA Is Aligning\u00a0With\u00a0ISO 13485<\/h2>\r\n<p><span data-contrast=\"auto\">The QMSR brings U.S. regulation in line with ISO 13485:2016\u2014with key FDA-specific additions. The update supports four key objectives:<\/span><\/p>\r\n<ul>\r\n\t<li><strong>Global consistency:<\/strong> <span data-contrast=\"auto\">ISO 13485 is already accepted or\u00a0required\u00a0in the EU, Canada, Australia,\u00a0Japan\u00a0and other major markets. Aligning with this standard makes it easier for U.S. companies to\u00a0operate\u00a0internationally without managing multiple systems.<\/span><\/li>\r\n\t<li><strong>Simplified compliance:<\/strong> <span data-contrast=\"auto\">A unified approach reduces the need for region-specific documentation and processes, supporting a more coordinated approach to quality system management.<\/span><\/li>\r\n\t<li><b><span data-contrast=\"auto\">Leveraging existing systems<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">Many U.S. manufacturers already hold ISO 13485 certification. The QMSR allows them to use this as a basis for meeting both FDA and global requirements more efficiently.<\/span><\/li>\r\n\t<li><b><span data-contrast=\"auto\">Streamlined auditing<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">The QMSR moves the U.S. closer to t<\/span>he <a href=\"https:\/\/www.fda.gov\/medical-devices\/cdrh-international-affairs\/medical-device-single-audit-program-mdsap\" target=\"_blank\" rel=\"noopener\">Medical Device Single Audit Program (MDSAP)<\/a>, whic<span data-contrast=\"auto\">h can allow a single audit to meet the needs of multiple regulators.<\/span><\/li>\r\n<\/ul>\r\n<p><span data-contrast=\"auto\">These shifts reflect the FDA\u2019s aim to modernize its oversight and support a globally integrated medical device sector.<\/span><\/p>\r\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\r\n<h2>What the FDA QMSR Means for U.S. Medical Device Manufacturers<span> <\/span><\/h2>\r\n<p><span data-contrast=\"auto\">If your organization already\u00a0complies with\u00a0the FDA\u2019s QSR (<\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">21 CFR Part 820<\/span><\/a><span data-contrast=\"auto\">), many of the principles within ISO 13485 will be familiar.<\/span><\/p>\r\n<p><span data-contrast=\"auto\">However, the updated regulations introduce differences in structure, terminology, and the emphasis placed on risk management and lifecycle control. These changes may require meaningful updates to your quality management system and processes, to meet the FDA-specific requirements. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\r\n<p><strong>Key\u00a0focus areas\u00a0could\u00a0include:<\/strong><\/p>\r\n<ul>\r\n\t<li><b><span data-contrast=\"auto\">Risk management<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">Proactive risk oversight is expected throughout the entire product lifecycle, not just during product design. ISO 13485 requires this risk-based approach to be embedded across all quality management system processes.<\/span><\/li>\r\n\t<li><b><span data-contrast=\"auto\">Design controls<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">Greater traceability, formal validation procedures, and comprehensive documentation are\u00a0required\u00a0to\u00a0demonstrate\u00a0that design outputs meet defined requirements.<\/span><\/li>\r\n\t<li><b><span data-contrast=\"auto\">Supplier oversight<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">Manufacturers must implement formal procedures for evaluating, qualifying, and\u00a0monitoring\u00a0suppliers and third-party providers. This supports product quality and regulatory accountability throughout the supply chain.<\/span><\/li>\r\n\t<li><b><span data-contrast=\"auto\">Complaint handling and post-market activities<\/span><\/b><strong>:<\/strong> <span data-contrast=\"auto\">Structured processes are\u00a0required\u00a0for investigating complaints, conducting post-market surveillance, and\u00a0initiating\u00a0corrective actions\u2014as outlined in ISO 13485.<\/span><\/li>\r\n<\/ul>\r\n<p><span data-contrast=\"auto\">These updates reflect international best practices and help support safer, more consistent manufacturing. Addressing them early can also support regulatory preparedness and improve readiness for FDA inspections or global audits.<\/span><\/p>\r\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\r\n<h2>Why ISO 13485 Certification Matters Under the QMSR<span> <\/span><\/h2>\r\n<p><span data-contrast=\"auto\">While\u00a0<\/span><a href=\"https:\/\/amtivo.com\/us\/iso-certification\/iso-13485\/\"><span data-contrast=\"none\">ISO 13485 certification<\/span><\/a><span data-contrast=\"auto\"> is not mandatory under the QMSR, it is encouraged, as it can help demonstrate conformance and offers recognized benefits across quality, credibility, and market access.<\/span><\/p>\r\n<p><span data-contrast=\"auto\">For organizations not yet certified, now is the right time to consider beginning the process.<\/span><\/p>\r\n<p><strong>Certification\u00a0to ISO 13485:2016\u00a0offers:<\/strong><\/p>\r\n<ul>\r\n\t<li><span data-contrast=\"auto\">Assurance that your organization has implemented a robust\u00a0medical device\u00a0quality management system that meets the requirements set in the standard and\u00a0aligns\u00a0with\u00a0updated FDA expectations.<\/span><\/li>\r\n\t<li><span data-contrast=\"auto\">Greater confidence in audit readiness and\u00a0outcomes.<\/span><\/li>\r\n\t<li><span data-contrast=\"auto\">Credibility with global partners,\u00a0regulators\u00a0and buyers.<\/span><\/li>\r\n\t<li><span data-contrast=\"auto\">Support for entry into regulated markets including the EU and Canada.<\/span><\/li>\r\n<\/ul>\r\n<p><span data-contrast=\"auto\">Early action\u00a0can also help reduce the complexity of the QMSR transition by ensuring that your systems are aligned with the standard the FDA is now using as its reference point.<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<h2>How\u00a0Amtivo\u00a0Can\u00a0Support\u00a0Your QMSR and ISO 13485 Transition<span> <\/span><\/h2>\r\n<p><span data-contrast=\"auto\">The FDA\u2019s move toward ISO 13485 marks a major step in the modernization of U.S. medical device regulation. It reflects a broader shift toward globally aligned quality\u00a0management\u00a0systems\u2014and a chance for manufacturers to position themselves for potential competitive advantage through improved process control,\u00a0assurance\u00a0and scalability.<\/span><\/p>\r\n<p><span data-contrast=\"auto\">Whether you are\u00a0starting from scratch\u00a0or adapting an existing system,\u00a0Amtivo\u00a0provides\u00a0trusted, accredited certification\u00a0services\u00a0to ISO 13485.<\/span><\/p>\r\n<p><span data-contrast=\"none\">Ready to pursue ISO 13485 certification? Explore our accredited <a href=\"https:\/\/info.amtivo.com\/hubfs\/Amtivo%20in%20the%20United%20States\/Amtivo-USA-Certification-Process.pdf\" target=\"_blank\" rel=\"noopener\">certification process<\/a> here or contact us to discuss audit scheduling and certification requirements.<\/span><\/p>\r\n<p>Explore more about\u00a0<a href=\"https:\/\/amtivo.com\/us\/iso-certification\/iso-13485\/\">ISO 13485<\/a>\u00a0here\u00a0or\u00a0<a href=\"https:\/\/amtivo.com\/us\/contact-us\/\">contact us<\/a> to discuss\u00a0certification.<\/p>","protected":false},"excerpt":{"rendered":"See Amtivo\u2019s expert insights on the FDA&#8217;s regulatory update and what this means for US Medical Device Companies. ","protected":false},"author":24,"featured_media":13127,"template":"","resource":[23],"resource-tag":[37],"class_list":["post-13126","resources-filter","type-resources-filter","status-publish","has-post-thumbnail","hentry","resource-insights","resource-tag-iso-13485"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>New FDA Quality Requirements - Medical Device Companies<\/title>\n<meta name=\"description\" content=\"See Amtivo\u2019s expert insights on the FDA&#039;s regulatory update and what this means for US Medical Device Companies. 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