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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…