This training course provides an introduction to the regulatory requirements for placing medical devices on the market. It will help participants to understand the regulatory pathway to CE marking a device.
As well as guiding delegates through the Medical Device Directive, this training course will provide information about other relevant guidance, standards and the new Medical Device Regulations.
Open to academics, researchers, clinicians and industry representatives, the one day course will cover:
- What is a Medical Device?
- The CE Marking process
- Notified Bodies, National Competent Authorities and Authorized representatives
- Clinical evidence for medical devices
By the end of the day, you will understand:
- The current medical device directives and the new Medical Devices Regulation
- How to classify medical devices
- How to CE mark a device
- What information is required for CE marking
- The role of the Notified Body and the National Competent Authority
- What clinical evidence is required to CE mark a product and the processes involved
This course is free to staff and postgraduate research students at Translate partner universities (Bradford, Huddersfield, Leeds, Leeds Beckett, Sheffield Hallam and York). Places for industry and clinical representatives are available at a cost of £300, please email Mohua Siddique to secure your ticket. Book now to avoid disappointment.
The training course will be run by Janette Benaddi, Medipex Associate.
About Medipex Ltd
Medipex is the regional NHS Innovation Hub for the Yorkshire & Humber region helping NHS staff commercialise their ideas and innovations.
About the trainer
Janette Benaddi 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 is the former owner of Medvance Clinical Research Ltd. and former Director of Clinical & Consulting Europe for NAMSA– a company which provides clinical research and regulatory consulting services to the medical device and healthcare industries worldwide.