Description
The FDA's Quality Management System Regulation (QMSR) replaces the existing Quality System Regulation (QSR) under 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. All medical device manufacturers marketing devices in the US must comply. Risk-based thinking must be embedded in all operations.
Requirements
- Transition from QSR to QMSR requirements
- Align quality management system with ISO 13485:2016
- Embed risk-based thinking in all operations
- Update documentation for QMSR compliance
- Prepare for new FDA inspection processes replacing QSIT
Applicable To
Medical Device ManufacturersMedical Device ImportersContract Manufacturers for medical devices
Penalty Information
âš FDA enforcement actions including Warning Letters, import alerts, seizure, injunction, and civil/criminal penalties.