Currently browsing "QMSR"
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5 Training Documentation Gaps FDA Investigators Find Under QMSR
Introduction On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) replaced the decades-old Quality System Regulation (QSR) as the governing framework for medical device manufacturing in the United States. Published in the Federal Register on February 2, 2024, the QMSR formally incorporates ISO 13485:2016 by reference — making compliance with that international standard […]
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The QMSR Deadline Has Passed. Is Your Documentation Ready for an FDA Investigator?
As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation (QSR), incorporating ISO 13485:2016 by reference into 21 CFR Part 820. The Quality System Inspection Technique (QSIT) has been withdrawn. The new FDA Compliance Program for inspection of medical device manufacturers is now in effect. This is not […]
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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 […]
