Lead Auditor EN ISO 13485:2021 and EU IVDR 2017/746 - Regulation


Instructor: Frank Stein
Product ID: 706891
Training Level: Intermediate

  • 17
  • April 2023
  • 08:00 AM PDT | 11:00 AM EDT
    Duration: 90 Min
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. These needs smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

April 17, Monday 08:00 AM PDT | 11:00 AM EDT
Duration: 90 Min


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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 EU IVDR 2017/746 requirements?
  • Overview about the changes of the EU IVDR 2017/746 regarding quality management
  • What is the relationsship between the EN ISO 13485:2021 and the EU IVDR 2017/746?
  • Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2021? The Role of the new harmonized version?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes

You might also wish to attend our comprehensive One-Day Virtual Seminar on Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation

Areas Covered in the Webinar:

  • The new scope of the EU IVDR 2017/746
  • The obligations and roles of the EU IVDR 2017/746
  • How work the regulation and the EN ISO 13485:2021 together?
  • New and updated processes required by the EU IVDR 2017/746
  • How to implement the required changes?

Who Will Benefit:

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

  • Medical device manufacturer
  • Importer
  • Distributors
  • Dealers

who work with European Union

Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, medical software, international project and regulatory consulting experience in Europe, North America, Asia, Australia, Latin-America.

Topic Background:

The regulation EU IVDR 2017/746 in the European Union has many new requirements. This regulation is also stronger connected to the EN ISO 13485:2021. The understanding of the changes regarding the previous regulation and how to implement is essential to keep your certificates up to date.

The first key for the understanding and the implementation of the changes is the knowledge about the relationship between the EN ISO 13485:2021 and the EU IVDR 2017/746.

The second key is to understand, which parts of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2021. These not covered paragraphs and requirements must be additional implemented into the quality management system.

The EU Commission publish monthly new MDCG guidance documents for deeper and more detailed understanding of the requirements and to give more clarification about the expectations by authorities and notified bodies.

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