InnoScot Health regulatory expert to speak at medical device webinar

InnoScot Health’s Head of Regulatory Affairs will be a key speaker at an informative webinar explaining the classification of medical devices and related regulations to a range of businesses.

Elaine Gemmell will help to lead the free online event entitled What is a medical device? taking place on Thursday 22 September at 10am, also involving speakers from The Medical Device Manufacturing Centre (MDMC) based at Heriot Watt University and Syntacog, developers of an online platform designed to support users navigate the regulatory landscape.

The combined technical seminar will see Elaine joined by Ms Melissa Siah, Director of Syntacog, and Prof. Marc Desmulliez, Manager of the MDMC.

Together, they 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

Elaine 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."

Elaine joined InnoScot Health, formally Scottish Health Innovations Ltd., in 2002 and helped establish the organisation. With more than twenty 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 laterally 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 startup in mid-2020. The company subsequently won the regulatory challenge in the 2021 Singapore Airlines AppChallenge and more than £500k 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.

Find out more

• Register to attend the event
• Read more about our Regulatory Advice Service