UCL Medical Devices Workshop

Please note: this event is for UCL staff only. You must register using your UCL email address or your order will be cancelled.

This is a joint event organised by the IHE Research Infrastructure and Translation & Industry Delivery Groups, in collaboration with UCL’s Joint Research Office (JRO) and Translation Research Office (TRO).

Who is this event aimed at:

• UCL staff at all career stages, who are working in the development of medical devices

At this event, you will learn about:

• the medical device regulatory landscape and the working definitions that can shape a researcher's experience of this journey
• the support available both within and outside UCL to help you navigate this landscape
• the actions and responsibilities researchers need to take

Provisional agenda

9.50 - 10.00 - Welcome by Professor Geoff Parker, IHE Deputy Director (Translation)

10.00 - 11.30 - Workshop: when is a product a medical device and what is the risk classification? Dr Rita Hendricusdottir, RegMetrics

11.30 - 11.45 - Break

11.45 - 12.15 - Standards in medical device regulations

What are they and how are they different?

• ISO 14155
• ISO 13485

12.15 - 13.00 - Regulatory authorities

Who are they, what do they do in the medical device regulatory landscape and how do they connect?

13.00 - 14.00 - Lunch

14.00 - 15.30 - Case studies

• Development of a high-risk medical device
• Academic of a medical device - lessons learned
• Defining 'in-house exemption' - Farhat Gilani, Clinical Trials Operations Manager, UCL Joint Research Office
• More to be confirmed

15.30 - 16.00

16.00 - 17.00 - Support and advice available at UCL