Immplementation of EU MDR, 13485:2016, & MDSAP

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.

SPEAKERS AND DETAILS

Speakers:

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