2025 SECTION MEETINGS
Dec 2, 2025
A Webinar on FDA's Quality System Regulation Presented by Dan O'Leary CMDA, CQA, CQE, CRE, SSBB
Meeting Date and Time
Tuesday December 2, 2025
From 1:30 pm Eastern to 3:30 pm Eastern
Cost is $295 per person. There is no group discount.
On February 2, 2026 FDA requires that all medical device manufacturers implement the new Quality Management System Regulation, QMSR. This is a major change that affects the medical device industry.
The webinar explains the changes and provides implementation guidance. The new regulation is a variant of ISO 13485:2016, so the webinar contrasts it with the European Union variant and explains its potential impact on the MDSAP Audit Approach.
You do not need to be a member to attend.
Register by going to https://mp.gg/aqwzpbo
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