FDA’s New Quality Management System Rule

Get expert insights on the U.S. FDA’s QMSR replacing the QSR and how to prepare before the February 2026 deadline.

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: FDA’s new Quality Management System Rule

Watch our on-demand webinar to learn key FDA QMSR changes and compliance steps before the 2026 deadline.

Webinar date

Sept. 11, 2025

Speaker

Linda M. Chatwin, Esq, RAC, lead regulatory and quality consultant

Quality Management System Regulation

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published its final rule for the new Quality Management System Regulation (QMSR) in the Federal Register. This rule amends the current Quality System Regulation (QSR), codified in 21 CFR part 820.

The revised Part 820 will be referred to as the QMSR. The final rule, as published, offers insight into the FDA’s thought process in issuing the rule. It also indicates that the QSR is amended to incorporate by reference the ISO 23485:2016 quality system standard, in addition to providing for other requirements.

In this webinar, the presenter:

Helps attendees develop a greater understanding of the changes to the U.S. FDA’s existing QSR, which becomes the QMSR.

Discusses updates needed for this change.

Shares some insights into preparing for compliance with the new rule.

About the presenter

Linda M. Chatwin, Esq, RAC, lead regulatory and quality consultant

Linda Chatwin has over 35 years of experience with medical products. Through years of watching regulations evolve and change, she knows how to navigate the global regulatory maze and helps bring products to market. Ms. Chatwin has obtained approvals for a wide range of products and is involved in changing the requirements for medical devices worldwide. She has navigated many FDA inspections, other regulatory authority audits, and has negotiated favorable outcomes with the FDA in various regulatory actions.

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