How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead

Janette Benaddi, RGN, BSc, MICR, CSci, CDir, MIOD, CEO, Medvance

Janette Benaddi is the CEO of Medvance™. The company provides clinical research and regulatory consulting services to the medical device and in-vitro diagnostic industries. Janette has over 20 years experience of managing pre and post market clinical studies in both devices and Pharmaceuticals. Prior to founding Medvance 14 years ago, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products.

Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist. She is Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.

Marcus Thornton, Senior Director, CTMS, Medidata Solutions

Marcus Thornton is Senior Director of CTMS at Medidata Solutions. Marcus came to Medidata Solutions with over two decades of experience in the life science industry and currently serves as senior director, CTMS. Marcus has dedicated his career to creating efficiencies in the clinical trial process. He worked at two biotechnology companies in the 1990’s and established a life sciences communications company working with Large Pharma, which he merged with an international e-solutions consultancy in Europe. Most recently, Marcus co-founded Clinical Force, innovating the development of clinical trial management systems.