Medical Device QMSR (ISO 13485)
Presented by Jeb Hunter
December 15, 2025 | 1 PM Eastern
In January of 2024, 21 CFR 820 was harmonized with ISO 13485 into the Quality Management System Regulation (QMSR), a regulation that better aligns the processes and requirements for a medical device facility with international standards utilized world wide.
This webinar will highlight the major changes to the regulations and give an overview of how the regulations have updated. Also covered are implementation of the new final rule, and what steps to take to best prepare for the start of enforcement by the FDA.
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About the Presenter
Jeb Hunter
Senior Regulatory Consultant
Jeb S. Hunter holds a BS in Microbiology from Clemson University and has spent his career in Quality, starting in a microbiology and chemistry laboratory setting and moving into auditing and managing Quality Management Systems. Jeb has experiences in the Pharmaceutical, Medical Device, Dietary Supplement, and Food/Tobacco industries. He is a highly capable team auditor and Lead Auditor across auditing platforms with audits conducted against a host of regulatory standards both domestic and international.
Posted in Webinar.