FDA QMSR Through The Lens Of Risk Management

Edwin Bills, Christie Johnson, and Jayet Moon describe how the new QMSR was shaped by ISO13485:2016 while still retaining its core. They explore how risk management is a key focus, with an emphasis on integrating risk-forward thinking throughout the QMS.

The authors share;

“On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. This regulation marks a pivotal transition from the guidelines previously stated in 21 CFR 820.5, forging a pathway toward an integrated approach that aligns with global standards. Now, under QMSR, Clause 4.1.1 of ISO 13485 requires organizations to document a QMS and maintain its effectiveness in accordance with the requirements of the standard and international regulations. This new regulation is not simply procedural; it is a foundational requirement since, ultimately, we are here to provide a system to help patients that is safe and effective.”

This article follows up on the wildly popular* May 24, 2023, Med Device Online article, The Intersection of ISO 13485 and ISO 14971 Under the Proposed FDA QMSR.

* most popular Med Device Online guest column of 2023!