Are you developing a device for the health sector? Are you unsure if you need to adhere to the Medical Device Regulations? Or what the risk classification of your medical device is according to the Medical Device Regulations? Or which requirements a medical device need to conform to? Then this workshop is for you.
The objective of this workshop is to learn the first key aspects of the medical device regulations: to determine when a product is a medical device, what the risk classification of the device is and what the next steps are.
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 I learn?
By the end of the workshop delegates 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 European Union(EU) risk levels.
- find the requirements that medical devices need to conform too
- hands on experience in using the regulatory tool: RegMetrics