The New Medical Device Regulation (MDR) brings about a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you embrace these changes and operate successfully in the new environment in Europe. It will cover in depth the new regulations and their implementation by the Member States and Notified Bodies. You will get to hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.
This seminar will provide key guidance and interpretation of the changes to the regulation and will be of value to all those who are involved in placing a medical device on the market, and anyone who requires an essential overview of the new medical device regulation and its impact on the industry and working practices.
Introduction and background to the new regulation
Key preparation for successful implementation
Notified Bodies: how the changes will impact NBs and manufacturers – including the new rules for IVD conformity assessment
Clinical investigations – what is required?
Increased vigilance and post-market surveillance – how to comply
IVDs and companion diagnostics
Other essential considerations
Panel discussion and key take-home messages
Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
Janette has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.