Navigating the FDA QMSR Transition: A Practical Gap Analysis Approach

Following the U.S FDA issuance of the Quality Management System Regulation (QMSR) Final Rule in January 2024, Medical Device Manufacturers have a limited window to be compliant with the changes that are coming into effect on February 2nd 2026, two years after publication.

The FDA is seeking to harmonize its regulatory framework with that used by other regulatory authorities, with one of the biggest changes being closer alignment with ISO 13485, the international standard for Medical Device Quality Management Systems (MD-QMS). This will impact Manufacturers in different ways.

On Wednesday, 19th November 2025, Comply Guru’s Michelle Keane will share insights and how she would approach a Practical Gap Analysis to determine FDA QMSR readiness.

She will discuss the following key topics:

1. Overview of the FDA’s QMSR and alignment with ISO 13485:2016
2. Key changes from the current 21 CFR Part 820 and their impact on manufacturers
3. How to conduct an effective gap analysis and prioritize remediation
4. Anticipated challenges and practical preparation steps for compliance
5. Q&A

Register for FREE to join this Webinar. Please note that registration is required to join this free live event.