As of February 2, 2026, the FDA will begin to enforce Quality Management System Regulation (QMSR), which is an amended version of the Quality System Regulation (QSR). The QMSR incorporates ISO 13485 and certain parts of ISO 9000. QMSR will improve the quality, safety, and efficacy of medical devices and will also help the United States to better align with other international regulatory agencies.

Attendees of the QMSR training course course learn how to:

Explain why we follow the FDA QMSR.
Identify general compliance expectations.
Identify the key elements of the QMSR.
Explain the key differences between the FDA QMSR and ISO Standards.