In collaboration with Oxford University, Bucks HSC Ventures is hosting an event to discuss regulatory requirements and ethical consideration for medical device and digital health innovators and startups. At this workshop you will learn about the key requirements, concepts, ethical considerations and the overall process for CE Marketing under the Medical Devices Regulation (MDR) which is required when bringing a medical device/ digital health solution to the market.

Who should attend?
People who are working in the area of medical devices / digital health solutions, including: academic researchers, clinicians, science students, innovators, start up’s, SME’s, research council, research services and tech transfer support.

What will you learn?
By the end of the workshop, you will be able to:
Identify if a device/ digital health solution is a medical device
Classify a medical device according to the Medical Device Regulation (EU) risk levels
Plan the next steps in the regulatory pathway
Describe the key requirements and concepts within the Regulations
Recognize the ethical considerations when bringing a medical device/ digital health solution to the market.

What’s included?
Light breakfast
Lunch
Refreshments