Clinical evidence is key to bringing a device to market and is a very important aspect of post-market evidence gathering to meet the legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.
This course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices. It will cover the full range of activities that should be applied during the collection of clinical evidence for both pre- and post- market studies and will also provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies and help them to run studies in Europe and other countries. Delegates will benefit from the advice and tips on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant with the new MDR.
The regulatory aspects of gathering clinical evidence for devices
Conducting a pre-market clinical evaluation and the literature review
Conducting a pre-market (regulatory) clinical investigation
Documentation for pre-market (regulatory) clinical investigation
How to obtain the necessary approvals for pre-market studies
The differences between drugs and devices
Study management and monitoring of regulatory clinical investigation
How to write a final study report for a regulatory clinical investigation pre-market study
Post-market clinical follow-up studies
Current key issues affecting clinical evidence for medical devices
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.
Robin Stephens is CEO & Principal Consultant, Psephos Biomedica a clinical, regulatory & quality consultancy in client-partnerships and/or interim management relationships with entrepreneurial corporations and venture-backed companies since 2001. Robin has more than 30 years experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe. Prior to his role with Psephos Biomedicca, Robin was the Director of QA/RA/CA for Apica Cardiovascular that is now part of the Thoratec Corporation. He was held senior roles with Conor Medsystems as well as Medtronic Vascular (previously AVE); and before that held several positions with CR Bard. Robin has been Scientific Adviser to a medical technology publishing house as well as being an author on regulatory matters and editor for a series of books on biomaterials. He holds a Masters Degree in Applied Theology from University of Wales, Bangor, a Bachelor of Science degree in Applied Chemistry from Northumbria University and is a member of the Royal Society of Chemistry.