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Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations

Post thumbnail Impact of the New Medical Device Regulation on Clinical Evaluations and Investigations

Developing and marketing a medical device in Europe has to follow the European law covered today by the Medical Device Directive (MDD). Since May 2017 the awaited new regulation for medical device (MDR) is now official as a Regulation. Using the transitional period which started, it is now time to prepare for the changes.

The following presentation will show you in a high level the new challenges and timelines that implementation of the new regulation will induced in the sake of performing a clinical evaluation and when and how to perform a clinical investigation for a medical device company.

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presentation by

Emmanuel Prades
Emmanuel Prades, M.Sc.
Senior Director, Clinical & Vigilance Operations
Heading the clinical trial submission and oprations team, Emmanuel provides technical expertise in clinical project management and strategy as well as…
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