EU MDR Implementation Strategies Virtual Workshop

About the Workshop

The new EU Medical Devices Regulation (EU MDR) will profoundly affect the medical device market in Europe.  Implementation deadlines are rapidly approaching.  Companies that have not already made significant progress in planning and preparation may be at risk of losing EU product registrations.  With notified bodies and consultants understaffed and overcommitted, help will be hard to find.

Anyone can read the regulation, but interpretation remains vague in some areas, and even the best prepared companies have large teams struggling with impact analysis, strategy, budgeting, and implementation.

This three half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies.  Pooling knowledge and strategies will help the industry as a whole better plan for the massive and costly upcoming changes.


PROGRAM OVERVIEW 

  • Economic Operators
  • Systems and Procedure Packs
  • Labeling & IFU (GSPR 23)
  • Implant Card (Article 18)
  • Clinical Evaluation
  • Software under MDR
  • Hazardous materials
  • Assignment of Basic UDI-DI
  • Article 117 and drug device combination products
  • Article 120(3)- Strategies for addressing the unknowns around what product changes can be made...
  • PMS under MDR
  • Art 88 - Trend Reporting
  • Eudamed
  • UDI
  • Your First experiences with NB MDR audits
  • Discussion - Notified Body/Competent Authorities: A Q&A opportunity for the audience to ask questions anonymously

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

SPEAKERS AND DETAILS

2020 Speakers:

  • Caroline Prisk, Senior Manager, Regulatory Affairs, Stryker
  • Sean Lilienfeld, VP Global Medical Affairs, Boston Scientific
  • Erik Vollebregt, Axon Lawyers
  • Melissa DeHaven, VP Global Clinical Operations, Boston Scientific
  • Michael Gyr, Sr Manager Regulatory Affairs EMEA, Varian Medical Systems
  • Keith Morel, Vice President, Regulatory Compliance, Qserve
  • Beatrice Wan, Senior Staff Regulatory Affairs Specialist, Stryker
  • Paul van Geffen, QA/RA Expert Senior Consultant, Qserve
  • Nic Pugliano, Regulatory Affairs, W. L. Gore & Associates, Inc. - Medical Products Division
  • Leonard Buchner, Biostatistics Expert, Qserve
  • James Wabby, Executive Director, Regulatory Affairs (Devices and Combination Products), Allergen
  • Anjali Gupta, Stryker Senior Manager, Regulatory Affairs, Stryker
  • Carol Romero, Stryker
  • Benedikt Sigurjónsson, Manager of Clinical Evaluation, Össur
  • Gert Bos, Executive Director & Partner Leading MDR-Expert, Qserve
  • Richard Houlihan, CEO, Eudamed
  • Leo Hovestadt, International Regulatory Affairs and Quality Assurance Director, Elekta

 

  • When

  • Tuesday, February 4, 2020 - Thursday, February 6, 2020
    12:00 PM - 5:00 PM

  • Where

  • Virtual Event

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