QMSR replaced the QSR on February 2, 2026, incorporating ISO 13485:2016 by reference. What actually changed for device manufacturers, what stayed the same, and what FDA investigators are finding in the first months of inspections.

CAPA deficiencies remain one of FDA's most reliable predictors of enforcement. What separating corrective and preventive action workflows looks like under QMSR, and what manufacturers actually need to change in their quality systems.

FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.