InnoScot Health and Heriot-Watt University will perform a joint presentation explaining the classification of medical devices and related regulations to a range of businesses.
Martin Shields
Elaine Gemmell, head of regulatory affairs at InnoScot Health
The two organisations recently signed a five-year agreement which will see Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) collaborate with InnoScot Health to help bring new ideas and innovations from healthcare professionals to life.
In a further step in the organisation's relationship, InnoScot Health’s head of regulatory affairs Elaine Gemmell and Prof. Marc Desmulliez, manager of the MDMC will help to lead a free online event entitled ‘‘What is a medical device?’ which is taking place on Thursday 22 September at 10am. The combined technical seminar will feature Elaine, Marc, and Ms Melissa Siah, director of Syntacog.
Together, the trio will be presenting on:
- The legal definition of a medical device
- The classification of a medical device and its impact on the regulations that need to be satisfied by this device
- Case studies of devices which lie at the boundaries between classes of devices
- The presentation of a software that automatically provides information on the classification of a medical device and lists the regulation documents to be filled in. A live demonstration of the software will also be provided
Gemmell said: “We expect this combined technical seminar to be of interest to manufacturers with little prior knowledge and experience of medical devices, as well as established businesses seeking more information on the automation of classification of medical devices.
“Joining the event will allow you to better understand the definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to.
“Before the pandemic, there was already movement towards increased governance around medical device innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices – from their manufacture to their use.
“A strong understanding of regulatory compliance must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.”
Gemmell joined InnoScot Health, formally Scottish Health Innovations, 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 has helped to establish the company with ISO 13485 accreditation and launch two innovative devices onto the market.
Prof. Marc Desmulliez has been involved in medical devices manufacturing for over 15 years. From his previous research interests in Microelectromechanical Systems (MEMS), and in collaboration with his former PhD student, Dr. Suzanne Costello, he developed some in situ sensors to look at the gas and moisture ingress in encapsulated packages. The work culminated in a monograph (Hermeticity Testing of MEMS and Microelectronic Packages, Artech House Pub). His current research interests include microwave sensing and nature inspired engineering.
Melissa Siah co-founded Syntacog, a regulatory start-up in mid-2020. The company subsequently won the regulatory challenge in the 2021 Singapore Airlines AppChallenge and more than £500,000 in Innovate UK grant funding to develop its regulatory compliance technology. Melissa’s passion for making regulations easier to understand comes from a decade in regulatory law and policy with the Australian government, and seven years leading the development of legal tech and AI products in the UK and Australia.
The webinar will be hosted on Zoom, with a link provided to attendees following registration here.
