FDA inspections under QMSR: the changes you need to be ready for

This whitepaper breaks down how FDA inspections are evolving under QMSR and what medical device companies need to do to stay prepared. It covers the shift away from QSIT, the new inspection models outlined in FDA’s Compliance Program Manual, the role of remote regulatory assessments, and how MDSAP fits into the broader oversight landscape.

We move beyond headlines and explain what these changes mean in practice. For quality and regulatory teams, this whitepaper offers a clearer view of what FDA may emphasize, where readiness gaps could surface, and how to strengthen inspection preparation before the next audit or inspection.