MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 25, 2024

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10:05 am

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12:00 pm

EU MDR and IVDR State of Play

International Track

Seven years after the go-live date of EU MDR and EU IVDR, Europe is still struggling to get through the transition. Yet, many elements of implementation have become clear, and the rollout is steadily progressing. This panel will discuss what we’ve learned, what we know, and how to move forward to close the gaps and finalize the transition. Time to press the accelerator and get back to the regular business of change management and much-needed innovation opportunities.

Moderators

Kim Trautman, Medical Device, IVD and Combo Product Expert

Gert Bos, Executive Director & Partner, CSO, CEO Qserve China, Qserve Group

Speaker

Kristen Hastings, Director of Design Quality, Haemonetics
Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD Medical Health Services
Colleen Watson, Senior Director of Regulatory Affairs, Thermo Fisher Scientific