Formal NHS Scotland partner InnoScot Health is partnering with fellow experts to offer a comprehensive learning programme on successfully delivering innovative medical devices

Designed for SMEs, healthcare professionals and researchers, the free online Continuing Professional Development (CPD) course is entitled Medical Device Regulatory Affairs: Management and Adoption of Healthcare Technologies and will be made up of four in-depth sessions taking place on the following dates:

• Thursday 24 October
• Thursday 31 October
• Thursday 7 November
• Thursday 14 November

Organisers say the course 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”.

The course aims to aid understanding of how to liaise with the medical sector so that a higher uptake of innovative medical devices can be achieved within care settings.

The four sessions will be hosted on Microsoft Teams – running from 10am to 4pm – and applications are now being invited for participation.

Successful applicants are advised that they are committing to attend all four dates and will receive their joining instructions a week in advance of the opening session.

Any questions can also be directed to [email protected].

Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) is pleased to be offering the course jointly with InnoScot Health, University Hospitals Bristol and Weston NHS Foundation Trust, the British Standards Institute (BSI), and NIHR Devices for Dignity.

The deep dive sessions were developed with support from Tay Health Tech via the UKRI EPSRC Place Based Impact Acceleration Account (PBIAA) Funding.

The provisional syllabus includes sessions focused on topics such as ‘Validation of clinical need, patient, public engagement and evaluation’, ‘Understanding Medical Device Regulatory Frameworks’, ‘Developing a technical file’, and ‘Emerging ideas and future challenges’.

The course will benefit from the knowledge and insights of eight expert speakers:

• Prof Marc Desmulliez, Manager of the MDMC
• Elaine Gemmell, Head of Regulatory Affairs, InnoScot Health
• Richard Scott, Director of Medical Physics and Bioengineering – University Hospitals Bristol & Weston NHS FT
• Lise Sproson, NHS Innovation Manager, NIHR Devices for Dignity Med Tech Cooperative
• Lena Cordie-Bancroft, Sector Lead – Medical Devices, BSI
• Prof Azzam F G Taktak, Head of Clinical Engineering – University Hospitals Bristol and Weston NHS FT
• Dr Tamer Y Cosgun, Technology Specialist – MDMC, Heriot-Watt University
• Brett Cohen, Clinical Scientist – Medical Device Governance, University Hospitals Bristol & Weston NHS Foundation Trust

Elaine – awarded the title of Honorary Professor of the School of Engineering and Physical Science at Heriot-Watt University last year – said: “This is set to be a highly instructive sequence of sessions, offering in-depth learnings to healthcare professionals, researchers, and SMEs.

“We expect that participants will gain comprehensive insights from what has been a popular course in previous years, and that participating will be highly beneficial to their ambitions.

“My contribution will be helping those taking part to 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.”

InnoScot Health and MDMC signed a five-year agreement in 2022, underlining their commitment to collaborate on helping to bring new innovations from healthcare professionals to life.

Elaine holds a BSc in Electronic Engineering and BEng (Hons) in Engineering and is Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University. Since joining InnoScot Health in 2002, she has gained more than 20 years’ experience in all aspects of medical device development and fifteen years in regulatory approval.

She is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval in United Kingdom, Europe and USA. She has held roles at Director and Senior Management levels in two InnoScot Health spinout companies.