FDA's New QMSR: Aligning with ISO 13485 and What It Means For You

Medical Device Global Market Access · Aug 12, 2025 · 3m

This episode dives into the FDA's monumental shift from the Quality System Regulation (21 CFR Part 820) to the new Quality Management System Regulation (QMSR). We break down the incorporation of ISO 13485:2016, the critical effective date of February 2, 2026, and the specific additions and changes manufacturers must be aware of. We cover the new terminology, the integration of other FDA regulations, and the significant impact on inspections and risk management. Key Questions: • What is the new Quality Management System Regulation (QMSR)? • When does the new QMSR become mandatory? • How does…