Solutions from leading global experts for the EU MDR chaos

Join us for this advanced workshop AT CINTAS CENTER, XAVIER UNIVERSITY:

  • Wednesday, March 27, 2019, 8:30am-5:00pm EDT

  • Thursday, March 28, 2019, 8:30am-4:00pm EDT

“Are you on track? A typical MDR transition program takes 30 months. The EU transition window has 20 months left.”

— Gert Bos

Expert leaders Bassil Akra (TÜV SÜD), Philippe Auclair (Abbott), Gert Bos (Qserve), and Kim Trautman (NSF) will lead you through the development of a time-critical action plan for keeping your medical devices on the EU market using proven strategies and tactics. At this workshop, you will develop:

  • Advanced strategies to effectively work with notified bodies.

  • Insightful game plans for compiling the data required to certify your products.

  • Recommendation plans to heighten awareness of the urgency to take action and gain support from senior leaders (CEO, COO, CQO, CFO, Chief Legal Officer, etc.).

Walk away with practical solutions to successfully prepare your company for the fast-approaching regulation deadline of May 26, 2020.


You Have Questions, and Time is of the Essence!

  • Will you need to spend millions to fulfill clinical data requirements on well-established technologies or legacy devices?

  • What do you need to do if your Notified Body has lost/limited designation?

  • How do you manage the increased cost of hiring, training and development of new resources?

  • How do you communicate with the EU Commission if the Eudamed database is not ready?

  • What are best practices for connecting postmarket surveillance to design changes under the new legislation?

Expert Leaders

Logistics

The EU MDR Workshop will be Wednesday, March 27, 2019, from 8:30am-5:00pm EDT - Thursday, March 28, 2019, from 8:30am-4:00pm EDT. Arrive at 7:30am and enjoy a complimentary warm breakfast before the workshop starts. For complete information on planning your trip to the workshop, click here.