FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026

Medical Device Global Market Access

This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to prepare for this transition. Key Questions: • What is the FDA's new Quality Management System Regulation (QMSR) issued on January 31, 2024? • How does the QMSR integrate ISO 13485:2016 into U.S. medical device regulations? • When is the critical effective date for the new QMSR requirements? • What are the main differences between the outgoing Quality System Regulation (QSR) and the incoming QMSR? • Beyond ISO 13485, what supplemental FDA-specific requirements must manufacturers address? • How will FDA inspections adapt to the new QMSR framework? • What actions should manufacturers prioritize during the two-year transition period ending February 2, 2026? • Is achieving ISO 13485 certification sufficient for QMSR compliance? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.