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.

FDA's voluntary Quality Management Maturity Program is quietly building toward a real quality rating system. Here's what it measures and what's at stake.

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.