EU ISO 13485:2016 Medical Device Quality Management System

This 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.

John E Lincoln
Instructor:
John E Lincoln
Date:
Wednesday, October 16, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502682

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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.

This 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. Also consideered are multi-site company operations, and the supply chain; trends evident in regulatory inspections; and recent major industry failures. The result will be a company proved to be "in control" to an investigator's satisfaction; the negative role of "entropy", and proactive and reactive inspection observation avoidance techniques.

Why should you Attend: 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.

Currently there is some confusion on the definition of "risk" among many under ISO 13485. The new MDR has also resulted in some major shifts in the emphasis regulatory compliance. These shifts have a major impact on interpretation of individual compliance objectives, and measurements of success.

Recent negative publicity in the regulated industries have put pressure on the Notified Bodies to "get tougher on compliance / enforcement", adding to the importance of reevaluating ISO 13485 compliance goals, especially in light of the new EU MDR. The compliance inspections, validations, submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.

Areas Covered in the Session:

  • Major Compliance Issues
  • The Tougher Regulatory Environment Shifting and New Emphasis
  • Changed Core Expectations
  • Basic ISO 13485:2016
  • Where does the EU's MDR Come In
  • What is "risk"?
  • Outsourcing and Globalization Issues
  • In-house Obstructions Before and During
  • Addressing the Notified-Body Certification Inspection

Who Will Benefit:
  • Senior management in Devices and Combination Products
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations


Speaker Profile
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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