Intersection of ISO 13485 and ISO 14971 under FDA QMSR

On February 22, 2022, the U.S. Food and Drug Administration (FDA) proposed changes to the Quality System Regulation (QSR), a set of rules established in 1996 to ensure the quality of medical devices. The FDA aims to update these regulations to keep pace with advancements in the field.

The proposed update suggests referencing ISO 13485:2016, a standard that outlines the requirements for quality management systems in the development of medical devices for regulatory purposes. This ISO standard has seen revisions and updates since its initial release in 1996, and the FDA is now considering incorporating these changes into its QSR.

It's noteworthy that the FDA's QSR has remained unchanged since 1996, and the proposal emphasizes the need to bring it up to date with current industry practices. Interestingly, ISO 13485 has undergone two revisions since its first edition, highlighting the divergence in the evolution of these regulatory guidelines. The FDA's initiative is aimed at aligning its regulations with the latest standards and best practices in the development of medical devices.

“In this article, we propose to show the intersections of ISO 13485:2016 medical devices quality systems standard and ISO 14971:2019 medical device risk management standard, which the FDA implied as key to the new regulation...”

Edwin Bills and Christie Johnson wrote the most popular guest column for 2023 at Med Device Online where, together, they dive deep into alignment on the definition of “risk”, where and how ISO 13485 references ISO 14971, plus the many implications on product realization, production, and post-commercial support.

Alternatively, download the file here. Contact us if you have any questions!