InnoScot Health and Heriot-Watt University will deliver webinar learnings around successfully achieving stateside medical device compliance.
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Last year, the two organisations signed a five-year agreement which would continue to 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.
InnoScot Health’s head of regulatory affairs Elaine Gemmell and Professor Marc Desmulliez, manager of the MDMC will help to lead a free online webinar entitled FDA Regulations on Medical Devices: How to Penetrate the US Market which is taking place on Friday 24 November at 10am.
The workshop – run by MDMC and Scottish Enterprise – will be hosted on Microsoft Teams with a link provided to attendees following registration.
Interested parties can alternatively opt to take part in the same interactive workshop held on two other dates next year – Wednesday 24 January and Wednesday 21 February.
All three sessions will feature Gemmell and Professor Desmulliez, as well as principal consultant at Compliance Solutions (Lifesciences), Edwin Lindsay.
The trio will be presenting an introduction to navigating medical device regulation as it stands in the UK and Europe, before shifting their focus to the demands of the United States’ Food and Drug Administration (FDA) where there are similarities but also significant differences for those looking to commercialise their products.
Gemmell said: “We expect these workshops to be of interest to manufacturers of all experiences and sizes who fundamentally recognise that negotiating compliance with a new medical device in any given country is an absolute must if they are to achieve market penetration there.
“Understanding the distinction between different territories’ regulatory processes is vital if they are to overcome challenges while opening up fresh opportunities for their commercial ambitions.
“Primarily, the sessions will aim to provide an overview of regulation in the US through real-life examples by first discussing what a manufacturer should consider when determining the strategy for introducing their new medical device into the UK market. This will then provide a counterpoint for explaining differing aspects in stateside regulatory processes – some marked, some not dissimilar.
“Joining the workshops will allow you to better understand the basic definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to wherever it is being targeted.
“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 – both preparing for it and then navigating it – must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.”
Gemmell joined InnoScot Health 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 InnoScot Health 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. With a BSc, BEng in Engineering, Elaine previously worked with Motorola Semiconductors for 20 years, gaining experience in manufacturing, design, and technical marketing.
Chartered engineer and physicist, Professor Marc Desmulliez is an expert in system integration, manufacture of medical devices and microwave sensing. As the Manager of MDMC, he is responsible for day-to-day operation of the Centre, as well as for ensuring sustainability of the MDMC beyond Scottish Enterprise funding (June 2026). In addition to his role at the MDMC, he is a serial entrepreneur responsible for the spinout of two companies and the start-up of a third one. He is also associate principal for Impact at Heriot-Watt University.
Edwin Lindsay has experience of working in the life sciences and medical devices/IVD industry for over 20 years and has expertise in regulatory affairs, clinical and quality working with many clients including Scottish National Blood Transfusion Service, EnteroBiotix, QSpine, Current Health, Abbott, Neurovalens, Teleflex, Gyrogear, Axis Spine, Vascular Flow Technologies, Kimal and Brightwake. He has worked with all classes of device from active to implantable, including custom devices, electronics, and software/artificial intelligence. Lindsay also lectures at University of Strathclyde and Glasgow University on medical device regulations.
