Currently browsing "QMSR"
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What the FDA’s New QMSR Means for Your Quality System — and Whether You’re Actually Ready
On February 2, 2026, the FDA replaced a regulation that had governed medical device quality systems for nearly three decades. The Quality System Regulation (QSR), which had structured how device manufacturers operated under 21 CFR Part 820 since 1996, gave way to the Quality Management System Regulation — the QMSR. The old framework is gone. […]
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QMSR Training Requirements: What Your LMS Must Do Now (2026 Edition)
What Your LMS Must Do Now (2026 Edition)
