InnoScot Health’s Head of Regulatory Affairs will be part of a team of experts dispensing key advice on medical device development during a four-week CPD course starting later this month

Elaine Gemmell is one of six specialists overseeing the 'Medical Device Regulatory Affairs Management and Adoption of Healthcare Technology’ course, starting on 25 October and running one day a week from 10am to 4pm up until 15 November.

Developed with support from the National Manufacturing Institute Scotland via The Scottish Government National Transition Training Funding, the interactive online course has been updated for 2022 to make it as relevant as possible for participants.

While the course – delivered jointly with University Hospitals Bristol and Weston NHS Foundation Trust, InnoScot Health, BSI and NIHR Devices for Dignity MedTech Co-operative – is aimed primarily at Scottish SMEs involved in medical device development, it is also expected to be of interest to healthcare professionals and researchers.

Elaine will be joined by a team of experts including:

• Prof. Marc Desmulliez, Manager of Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC)
• Richard Scott, Director of Medical Physics and Bioengineering at University Hospitals Bristol & Weston NHS FT
• Vicki Stone, Professor of Toxicology and Director of the Institute of Biological Chemistry, Biophysics and Bioengineering (IB3) at Heriot-Watt University
• Lise Sproson, Professor of Toxicology, and Director of the Institute of Biological Chemistry, Biophysics and Bioengineering (IB3) at Heriot-Watt University
• Emma Glass, University Partnerships Manager for Healthcare Technologies in the Knowledge Solutions division of the British Standards Institute (BSI)

Syllabus topics covered will include ‘Understanding Medical Device Regulatory Frameworks,’ ‘Medical Device Classification and Risk Assessment,’ ‘Developing a Technical File,’ and ‘Emerging Ideas and Future Challenges.’

MDMC is currently inviting interest – though places on the course are limited so early application is considered essential to assure a place. The deadline for applications is 21 October at 11:45pm.

Further course details can be found on the online booking form. Any questions about the programme can also be directed to mdmc@hw.ac.uk.

Elaine said: “This CPD course has proved popular in previous years, and we expect it will be the same this year as it helps SMEs, healthcare professionals, and researchers gain a strong understanding of how to liaise with the medical sector so that a higher uptake of innovative medical devices can be achieved within care settings.

“Fundamentally, it 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 helping participants better understand such vital areas as the definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to.”

Elaine joined InnoScot Health, formerly Scottish Health Innovations (SHIL), in 2002 and helped establish the organisation. With more than 20 years’ experience in medical device development, she is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval and CE, UKCA marking for medical devices. Joining SHIL spinout company, Clear Surgical, as a Director, Head of Regulatory Compliance and latterly Chief Operating Officer, she helped to establish the company with ISO 13485 accreditation and launch two innovative devices onto the market.

InnoScot Health and Heriot-Watt’s MDMC recently announced a five-year collaborative partnership which aims to fast-track innovation in medical and healthcare technologies and better understand clinical and nursing needs in Scotland.