Webinars > All COMPLIANCE Categories > Compliance Courses Webinars EU ISO 13485:2016 Medical Device Quality Management System WebinarThis webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU. Course Description/AgendaEU ISO 13485:2016 Medical Device Quality Management System Overview:
This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation). Discussed are the EU's Notified-Bodies mandate to get tougher across the board in their expectations for the medical products industry and its compliance to the standards / regulations.
In the US we have the CGMPs, specifically 21 CFR 820, for Medical Devices. Europe has the ISO 13485;2016 standard to define their Medical Device Quality Management System. ISO 13485 now has an almost idential design control requirement. And there are many other similarities, as both QMS' strive for global harmonization. But to obtain the CE-mark, conformance to ISO 13485 together with the EU's MDD / MDR, are the requirements. Areas Covered in the Session:
Who Will Benefit:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
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