New QMSR Training Modules Explain Upcoming FDA Medical Device Regulations

Two new training modules from the U.S. FDA’s Center for Devices and Radiological Health (CDRH) provide an overview of the Quality Management System Regulation (QMSR), which will take effect on February 2, 2026.

In the first module, “Navigating the Quality Management System Regulation (QMSR)”, Tonya A. Wilbon outlines the purpose, scope, and key requirements of the QMSR, referencing ISO 13485:2016 and ISO 9000:2015. The slides compare the 1996 and 2024 versions of 21 CFR Part 820, explaining how the new rule incorporates ISO standards by reference (IBR). Related regulations such as 21 CFR 830, 821, 803, and 806 are also noted. The FDA recommends a four-step implementation process: understand the regulation, perform a GAP analysis, establish documentation, and foster a culture of compliance.

A second module focuses on risk management within QMSR, highlighting risk-based decision-making and examples of risk documentation. Both modules are available on the CDRH Learn website.

19-10-2025