Wellcome / EPSRC Centre for Interventional and Surgical Sciences


Introduction to Medical Device Regulation workshop

12 February 2018

We have received EPSRC Training Funds to run a two day workshop this year providing an "Introduction to Medical Device Regulation" for students working within the WEISS Centre or other medical device development projects across the university.


Translation of technologies such as robotics, computer software and biotechnologies into clinically usable medical devices requires compliance with regulatory requirements. Researchers and students working in leading-edge healthcare and medicine areas are not provided with any education as standard in the regulatory requirements to translate their research to the clinic. They are often left to find their own way which can delay the translation by many years. 

This workshop aims to combat that by giving students an overview of the new EU medical device regulation, expected design and development phases of device development, how to identify and manage risks and the data required to support a clinical trial application.

The course will be run by external trainers and has been customised to meet the needs of researchers working within an academic setting. The students will gain skills in risk management and design planning, and will be provided with the necessary information to make informed decisions on what testing to perform to verify and validate their designs.

The workshop is eligible for CPD accreditation and all participants will be provided with a certificate of attendance. 

Look out for more details coming soon.