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.
Emmanuel Prades, Director Clinical Operations
After 22 years in many diverse clinical research departments, in both pharmaceutical and medical device industries, Emmanuel has significant experience in the management of international clinical studies (all phases) from protocol writing to reporting. He also has experience in overall project management, Clinical Quality Assurance, pre-market vigilance for Medical Device and coordination of multiple functional teams and subcontractors.