Translate Me: Regulatory Affairs for Medical Devices
This workshop 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 workshop will also provide information about other relevant guidance, standards and the new Medical Device Regulations.
The day will cover
What is a Medical Device?
• How do you determine if your product is a medical device?
• What regulations govern the marketing of medical devices?
• How are devices classified?
The CE Marking process
• How do you get a CE mark for your device?
• What is the process?
• What regulations, guidance and standards do you need to follow and what documentation do you need?
Notified Bodies, National Competent Authorities and Authorized representatives
• Who are they?
• What do they do?
Clinical evidence for medical devices
• What evidence do you need?
• When and how do you collect it the evidence?
• What are the regulations and guidance applicable to medical device clinical studies?
By the end of the course, delegates will be able to 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
The workshop will be run by Janette Benaddi, Medipex Associate.
Medipex is the regional NHS Innovation Hub for the Yorkshire & Humber region helping NHS staff commercialise their ideas and innovations.
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 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.
Spaces are limited and registration is essential. Open to staff and postgraduate research students at Translate partner universities only.Book now to avoid disappointment.Book now