This is an invite only event, but there may be spaces available. If you would like to enquire about this, please head to our contact page and get in touch.
This full day session will be led by Janette Benaddi, a business mentor, international speaker/trainer and expert 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. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. In addition, she set up a very successful medical device CRO company in the late nineties which she later successfully sold to another large multinational organization in 2013. 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 investigations/evaluations for the medical device industry, she has also provided training to Notified bodies on medical device studies as well as other medical companies.
The objective of this training is to provide participants with a comprehensive understanding of medical device clinical evaluation, including regulatory requirements, methodologies, and best practices. Through workshops and case studies, participants will gain practical experience in conducting clinical evaluations for medical devices.