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.
Training format
Topic
Live online
This course provides UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK.
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Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
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Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR.
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This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
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Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Summer school
Classroom
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
Live online
How to produce quality regulatory documents including the clinical evaluation report (CER).
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