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

Speaker

Instructor: Frank Stein
Product ID: 706165
Training Level: Intermediate to Advanced

Location
  • 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. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
RECORDED TRAINING
Last Recorded Date: Aug-2020

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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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 is the relationsship 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?
  • 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 2-day virtual seminar on Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

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

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 new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement is essential to keep your certificates. The first key for the understanding and the implementation of the changes is the knowledge about the interfaces between the EN ISO 13485:2016 and the EU MDR 2017/745. The second key is to understand, which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system since May 2021. The EU Commission publish monthly new guidance documents for deeper understanding of the requirements and to give more clarification about the expectations by authorities and notified bodies.

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