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

Event Details

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

Time: May 5, 2022 from 10am to 1pm
Location: online
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: webinar
Organized By: Complianceonline
Latest Activity: Apr 20, 2022

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Event Description

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.

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

Who Will Benefit:

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

  • Medical device manufacturer
  • Importer
  • Distributors
  • Dealers

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