EAS Webinar: FDA’s Transition from CFR 820 to the ISO 13485

EAS Webinar: FDA’s Transition from CFR 820 to the ISO 13485:2016 - Instituting a New Quality Management System (QMS)

September 25, 2019

Presented by George Yanulis, D.Eng., EAS Independent Consultant

FDA’s shift to a to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those operating under 21 CFR 820 Quality Management Systems made the voluntary switch?

While ISO 13485 is an international standard, its focus on design

Contributor
George Yanulis
Fort Myers, Florida
Materials Science
(216) 571-1532

About
Dr. Yanulis is an experienced medical device research and development engineer and medical device expert witness.