Supplier Management with the new Medical Device Regulation EU MDR 745/2017

The implementation deadline of EU MDR 745/2017 is 2020. This webinar will help you learn how to quickly implement it in a simple way and pass the Quality Management Audit by your certification company or notified body. It covers the topic of supply chain and the interfaces to the EN ISO 13485:2016.

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

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(PPT + Recorded Training File)

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Why Should You Attend:

One of the hot topics of the new medical device regulation EU MDR 745/2017 in the European Union is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Additional activities are required by both the ISO and the MDR. Care should be exercised with outsourced processes. These activities are both on the classic supplier side and on the other side of the company in the field of sales and post market activities. It is important to understand these changes to keep your certificates ready and prevent doing them in the last minute.

This webinar will help you understand what changes are made to the new medical device regulation EU MDR 745/2017 in the European Union, how to implement them into your existing quality management system in a quick and simple way. The webinar will provide smart ideas to pass the quality management audit by your certification company or notified body within the short timeline.

The webinar will describe the following vital topics:

  • Introduction, who must apply the new EU MDR 745/2017 requirements
  • Overview about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities.
  • Explaining of each change
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
  • Who is responsible for the activities?
  • Which (new) roles in the company required?
Areas Covered in the Webinar:
  • Closer regulatory binding of the ISO to the new EU MDR
  • Responsibilities for outsourced processes
  • What are outsourced processes?
  • Adjustments in the management review
  • Adjustments in the audit process
  • How to onboard the supplier?
  • Examples from outsourced R&D-, manufacturing-, lab-test - processes
  • Examples from outsourced sales processes
Who Will Benefit:

CEO’s, purchasing manager, quality/regulatory affairs manager, quality representatives of

  • Medical device manufacturer,
  • Importer,
  • Distributors and
  • 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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