InnoScot Health will be offering leading expertise on medical device development this autumn as part of a CPD course taking place in a highly accessible hybrid format

The two-day ‘Management and Adoption of Healthcare Technology’ course will provide an overview of regulatory affairs for medical devices and how their integration fits with the management of healthcare technology.

It has been organised by the Medical Device Manufacturing Centre (MDMC) and will be delivered on Thursday 27 November and Thursday 4 December.

The former date will see InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell delivering two consecutive sessions, entitled ‘Understanding Medical Device Regulatory Networks’ and ‘Developing a Technical File’, starting from 9.30am.

The course — including contributions from MDMC, InnoScot Health, Edinburgh Clinical Trials Unit (ECTU), Citizen Medtech, Firefinch Software, Medtronic, and NIHR Devices for Dignity — will be available to attend both in-person at Edinburgh’s Heriot-Watt University and online through Microsoft Teams.

Limited places are available to help ensure good participant interaction and early application is encouraged.

Elaine said: “I am delighted to be supporting this in-depth course and look forward to presenting as part of an insightful knowledge transfer-themed day.

“Following previous iterations, we know that the course’s learnings are well-received, so it’s great to have the opportunity of offering it to further parties with flexible options for attendance in place, ensuring greater accessibility.

“Fundamentally, it will provide an overview of medical device regulatory affairs and how their integration fits with the management of healthcare technology and the processes involved in adopting and monitoring medical devices.

“We expect SMEs, healthcare professionals, and researchers to benefit most from the course, allowing them to access valuable, wide-ranging knowledge on how to work closely with the medical sector, engendering a higher uptake of innovative medical devices within care settings.

“My own contribution will predominantly focus on helping participants better understand vital areas of medical device regulations which the device needs to comply to — a key consideration in progressing ambitions.”

Kicking off the first day will be an introduction and overview, including breakout sessions, from Marc Desmulliez, Manager of the MDMC.

The afternoon of 27 November will see further sessions on ‘Medical Device Classification and Risk Assessment’, and a ‘Practical introduction to key standards’.

Day 2 on 4 December will be entitled ‘Application & Emerging Topics’ and will include sessions on ‘Validation of clinical need, patient, public engagement and evaluation’, ‘Healthcare technology adoption and management’, and ‘Evaluation, usability and sustainability of medical devices’.

The course has been developed with support from Tay Health Tech via the UKRI EPSRC Place Based Impact Acceleration Account (PBIAA) Funding.