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

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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$249.00
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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Aug-2020

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(PPT + Recorded Training File)

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

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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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