Event Description
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation 2022

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

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
End Date
Start Date
Event Speciality
Venue
Event Cost:
249
Event Types (Select all that apply)
Medical Conference
Medical Seminar
CME Credits
Yes
Abstract Submission Deadline
(+1) 206-575-7771
Medical Events Worldwide
12922 SE 299th Street, Auburn WA 98092 USA