Sylvie le Gledic, Director, Medical Devices & IVD will be presenting 'Demonstration of clinical evidence according to the requirements of the IVDR: the special case of companion diagnostics.' during the Session 1 - Preparing for compliance with the EU MDR and IVDR.
The presentation will take place on Tuesday 16th October at 10.00.
About the speaker
Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs). Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System.Contact Sylvie