Global Community

Hi Community, sharing an update for my ISO 13485 / medical device colleagues.

The FDA's Quality Management System Regulation (QMSR) amends 21 CFR Part 820 to align with ISO 13485:2016, replacing the legacy QSR and harmonizing U.S. medical device quality requirements with international regulatory frameworks.

The QMSR embeds risk management and quality system effectiveness throughout the regulation and supports a risk‑based inspection approach. Manufacturers must establish and maintain a compliant QMS to meet FDA requirements and ensure continued product conformity.

This alignment also strengthens FDA reliance on ISO 13485‑based conformity assessment programs, including the FDA Accredited Third‑Party Inspection Program and MDSAP, supporting global regulatory convergence and more efficient oversight.