QMSR removed the exemption that long kept supplier audit records out of FDA investigators' reach. What that means for supplier and outsourcing controls under ISO 13485, and how to get supplier audit files inspection-ready.
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'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.
