Currently browsing "QMSR"
-
The FDA’s QMSR Deadline: What Medical Device Manufacturers Must Know Before February 2, 2026
Medical device manufacturers face a regulatory milestone that will fundamentally reshape quality management requirements in the United States. On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) replaces the existing Quality System Regulation (QSR), incorporating ISO 13485:2016 by reference into 21 CFR Part 820. This isn’t a grace period or transition window—it’s a […]
-
FDA QMSR Explained: What Medical Device Companies Must Know Before 2026
The U.S. Food and Drug Administration finalized the Quality Management System Regulation (FDA QMSR) in February 2024, replacing the Quality System Regulation (QSR) that has governed medical device manufacturing since 1996. This FDA QMSR represents a fundamental shift toward harmonizing U.S. regulations with ISO 13485:2016, the internationally recognized medical device quality management system standard. Medical […]
