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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Sample of the presentation
presentation by
Emmanuel Prades, M.Sc.
Senior Director, Medical Devices
With over 20 years in Clinical development in diverse areas from pharmaceutical to medical device industry, Emmanuel has broad technical expertise in clinical trial regulations and associated country-specific requirements and has extensive experience in various trial phases, product types, indications, and geographical areas. He has extensive experience in strategic clinical decision meetings with various cross-functional activities for regulatory, safety, quality, and study organization. He also has experience in quality as a clinical QA advisor (audit, SOP writing, Team training).
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