The MedTech Conference 2019

ICON is transforming trials to help bring more cost effective medical devices & diagnostics to market

Meet ICON Experts at The MedTech Conference 2019, Booth 206

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Super Session: MDR / IVDR – What Now?

Tuesday, September 24, 2019, 3:45 - 5:00 p.m.
Location: Room 156 AB

Angela Brown, B.S.

Director, Regulatory Affairs, Medical Device and Diagnostics Research

Implementation of the MDR/IVDR remains problematic. Relevant and necessary implementing acts remain in limbo, notified body capacity does not appear sufficient to be able to do the necessary reviews in advance of the deadlines and many additional technical questions remain unresolved. This panel will address the fundamental issues in implementing the regulations, as well as attempt to offer perspective on potential mechanisms that could be utilized to reduce the review backlog and ensure products can remain on the market in the EU. The panel will have a wide representation from industry, regulators, consultants, and notified bodies. The session will provide a comprehensive update of the scenarios that are likely to unfold in the coming months and offer insight into how these may be addressed.

Additional Speakers

  • John Wilkinson, MBA, Director of Devices, Medicines and Healthcare products Regulatory Agency (MHRA), U.K.
  • Oliver Bisazza, Master of Economic Sciences, Director, Regulations & Industrial Policy, MedTech Europe
  • Michel Marboeuf, MBA, Senior Director Regulatory Corporate, Stryker

2019 Medtech Insight Awards

ICON is delighted to be the lead sponsor for the 2019 Medtech Insight Awards, an evening to honor those who, through their passion and unwavering commitment, are driven to cure, inform, minimize treatment burden, and make human lives better.

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