Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System

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 considered 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 You Should 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 identical 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 :

  • What are EU Notified-Body expectations under ISO 13485 and the MDR – with the recent major revisions to both?
  • The Tougher Regulatory Environment Shifting and New Emphasis
  • How can a company develop and maintain a dual QMS.
  • Basic Systems / SOPs.
  • Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
  • Current areas of EU concern.
  • Outsourcing and Globalization Issues
  • In-house Obstructions Before and During
  • Maintaining compliance under increasing regulatory expectations.
  • Similarities and differences in the FDA and EU QMS’

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Software Developers
  • Senior and Middle Management


John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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