|THUASNE SA||Director, Regulatory Affairs||France|
| Final stretch to MDR/IVDR implementation: How are companies revising their strategy to comply with the key requirements and associated timelines? |
Carole Robin had received a Pharmacy Doctor degree from the University of Lyon (France) and a master degree in Quality Management System.
She has prior experience working for Japan, US based and French companies for medical devices, drugs and cells therapy products, for more than 28 years. In Regulatory Affairs she prepared and managed EC marking and international files. As RA International Director in previous experience, she has developed, implemented and maintained regulatory strategies and guidance based on International requirements. She has been involved in different groups at MedTech Europe, and the French one, snitem.
She has also experience in Quality in establishing and maintaining ISO13485 and In Clinical Research, she was responsible for preparing, managing more than 20 international clinical trials of medical devices, drugs, and biotechnology products.
Today, Carole is responsible for assuring compliance for Medical Device Regulation, export, Post Market Surveillance including Clinical evaluation at Thuasne, a French company. Lastly with snitem, she participates actively in the Medical Device Regulation groups.