Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

Instructor: Frank Stein
Product ID: 706165
Training Level: Intermediate to Advanced
  • Duration: 90 Min
Attend this webinar to understand the changes of the new EU MDR 2017/745 regarding quality management, the EN ISO 13485:2016 and the EU MDR 2017, and how to implement the changes to fast track internal audit.
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Read Frequently Asked Questions

Why Should You Attend:

This webinar will provide an in-depth understanding into the following

  • Introduction, who must apply the new EU MDR 2017/745 requirements?
  • Overview about the changes of the EU MDR 2017/745 regarding quality management
  • What are the interfaces between the EN ISO 13485:2016 and the EU MDR 2017?
  • Which new requirements of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes

Areas Covered in the Webinar:

  • The new scope of the EU MDR 2017/745
  • The obligations and roles of the EU MDR 2017/745
  • How work the regulation and the EN ISO 13485:2016 together?
  • New and updated processes required by the EU MDR 2017/745
  • How to implement the required changes until May 2020?

Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • Medical device manufacturer
  • Importer
  • Distributors
  • Dealers
Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

Follow us :
Fundamentals of EU MDR and IVDR
Advertising and Promotional Requirements for Drugs and Medical Devices

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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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