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  • FDA Final Rule: ISO 13485 Now Central to U.S. Medical Device QMS – Are You Fully Aligned?
    What SME Manufacturers Need to Know—and How QNET Can Support You The U.S. Food and Drug Administration (FDA) finalized its Quality Management System Regulation (QMSR), marking the most significant overhaul of U.S. medical device quality system requirements in over two decades. The new regulation formally integrates ISO 13485:2016 into 21 CFR Part 820, aligning U.S. expectations with the internationally recognized standard already used in the EU, UK, Canada, and many other jurisdictions. While this alignment has been widely anticipated, its practical implications for SME manufacturers are substantial. From Awareness to Execution Most SME medtech companies are already working with ISO…

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