Medical Device Single Audit Program (MDSAP) Audit Approach (AU P0002.010)

The Medical Device Single Audit Program (MDSAP) released a revised audit approach on February 6, 2026. The revised audit approach was released to account for the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) that occurred on February 2, 2026.

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