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 two-day conference 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.

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.



  • Bassil Akra – VP, Global Focus Teams, TÜV SÜD
  • Tony Blank -– President & CEO, Infinity Biomedical Group; former VP, Regulatory Affairs, CRV Group, Boston Scientific
  • Matthias Bürger – VP, Global Regulatory Affairs, Zimmer Biomet
  • Patrick Caines, PhD – Senior Director, Quality & Compliance, Baxter Healthcare
  • Conor Dolan – VP, Global Quality Systems, Boston Scientific
  • Uwe Degenhardt – Director, Quality Compliance, Edwards Lifesciences
  • Kristin Dudek – Senior Staff Regulatory Affairs Specialist, Stryker
  • Gina Gettelman – Sr. Program Manager – EU MDR, Global Regulatory Affairs, Medtronic
  • Keith Morel, PhD – VP, Regulatory Compliance, Qserve
  • Judith O'Grady - Corporate VP, Global Regulatory Affairs & Corporate Compliance Officer, Integra Life Sciences
  • Fabien Roy – Partner, Hogan Lovells
  • Maria Samuel – Divisional Quality Leader, W L Gore
  • Michael Santalucia – VP, Regulatory Affairs, Terumo BCT
  • Ibim Tariah – Technical Director, BSI
  • Rosa Vera - Sr. Director, Program Management Office, Healthcare Transformation Services, Philips Healthcare
  • Weiping Zhong – Director of Risk Management, GE Healthcare
  • Other speakers to be announced


  • When

  • Tuesday, November 27, 2018 - Wednesday, November 28, 2018
    8:30 AM - 4:00 PM

  • Where

  • Washington, DC 20004

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