InnoScot Health will be offering expertise on medical device development as part of a CPD course taking place across two days in a flexible new hybrid format

The ‘Management and Adoption of Healthcare Technology’ course has been organised by the Medical Device Manufacturing Centre (MDMC) and will be delivered on Tuesday 29 April and Tuesday 6 May.

The former date will see InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell delivering two consecutive sessions, entitled ‘Understanding Regulatory Medical Device Networks’ and ‘Developing a Technical File’, from 10am.

The course — delivered by MDMC with contribution from InnoScot Health, the British Standards Institute (BSI), Citizen Medtech, and NIHR Devices for Dignity — will be available to attend both in-person at Edinburgh’s Heriot-Watt University and online through Microsoft Teams following previous feedback.

Elaine said: “I am proud to have been asked to lend my knowledge to this and look forward to presenting as part of an insightful knowledge transfer-themed day.

“The course has previously proved popular, so it’s great to have the opportunity of bringing it back, particularly with more flexible options for attendance.

“Its learnings will primarily be for the benefit of Scottish SMEs involved in medical development.

“Nevertheless, we expect healthcare professionals and researchers to also get a lot out of it and all will gain a deeper understanding of how to most effectively liaise with the medical sector so that a higher uptake of innovative medical devices can be achieved within care settings.

“Fundamentally, the course provides 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.

“My contribution will be predominantly about helping participants better understand such vital areas of medical device regulations for which the device needs to comply to.”

Elaine added: “I would ask those interested in the course to bear in mind that with limited places available in order to encourage interaction, early registration is therefore recommended.”

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

The afternoon of 29 May will see further sessions from MDMC Technology Specialist, Tamer Cosgun, on ‘Medical Device Classification and Risk Assessment’, and Sector Lead for Medical Devices in BSI’s Knowledge Solutions division, Lena Cordie-Bancroft, on a ‘Practical introduction to key standards’.

Day 2 on 6 May 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.