Quality Management System (QMS) Workshop for Medical Device Investigators

Sponsored by the UCL Devices & Diagnostics TIN and the UCL Institute of Healthcare Engineering Translation and Industry Delivery Group, this online workshop will provide guidance on the regulatory requirements in medical device development, quality management systems (QMS) and facilitating the translation of early academic devices to later-stage, commercially attractive assets.

Agenda:

1. Simon Eaglestone (TRO) - Why bother with a QMS?
2. Sarina Hussain (MPBE) - What is a proportionate QMS?
3. Farhat Gilani (JRO) - When & how do you engage with the Sponsor and MHRA?
4. Workshop discussion

Please note this event is for UCL only. You must register with a relevant email address to gain access.

The workshop will benefit those seeking greater understanding of regulatory considerations for the progression of innovative medical devices (whether hardware or software) from the laboratory, through clinical evaluation and ultimately toward market authorisation.

The program is pitched to help Early Career Researchers adopt best practice of quality management and documentation from the start of the device development life-cycle, as well as though later-stage investigators who are approaching the ‘exit’ of their academic device either by ‘spinning out’ or licensing to a commercial medical device manufacturer.