This two day course will cover all the aspects of clinical evaluation in line with the European Medical device regulations and applicable guidance documents. The course will provide you with the tools and skills you will need to produce a high quality clinical evaluation report for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a clinical evaluation report that is acceptable to the Regulatory Authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post market aspects of clinical evidence. The course includes case studies and template documents which you will be able to utilise to produce your own high quality clinical data evidence documentation.
Objectives and overview
What is a clinical evaluation?
Why and when is it necessary to conduct a clinical evaluation?
Who and what is involved in the clinical evaluation process?
Workshop : Bringing it together
What regulations govern clinical evaluations and what guidance documents should clinical evaluations be conducted to?
Q & A and wrap-up of day one
Review of day one, introduction to the day, objectives and overview
Documentation necessary for conducting a clinical evaluation
The literature review process
The Clinical Evaluation Report (CER)
What is state of the art and how to conduct a risk benefit assessment of the data?
Impact of the Medical Device Regulations (MDR)
Q & A and wrap up
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 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. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she 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.