Joint workshop announced on achieving medical device compliance in USA

Formal NHS Scotland partner InnoScot Health is set to link up with others this month to deliver free webinar learnings on successfully delivering stateside medical device compliance.

An online workshop for companies aiming to navigate the specific processes of America’s Food and Drug Administration (FDA) is being presented alongside Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) and CS Lifesciences.

Following successful workshops on the same subject last year, the presenting organisations agree that it is vital to “discuss what a manufacturer should consider when determining the strategy regarding entry into the US market for a new medical device”.

Elaine Gemmell, InnoScot Health’s head of regulatory affairs

InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell, Managing Director of Compliance Solutions Edwin Lindsay, and Professor Marc Desmulliez, Manager of the MDMC, will lead the webinar entitled FDA Regulations on Medical Devices: How to Penetrate the US Market, taking place on Wednesday 23 October from 10am.

The deep dive workshop – run by MDMC and Scottish Enterprise – will be hosted on Microsoft Teams and is the first of three on the same subject. Interested participants can now register interest for 23 October and will be supplied with joining instructions.

All sessions will feature speakers Elaine – awarded the title of Honorary Professor of the School of Engineering and Physical Science at Heriot-Watt University last year – Marc, and Edwin.

Marc will be presenting an introduction to navigating medical device regulation as it stands in the UK and Europe, before Elaine and Edwin shift the focus to the demands of the FDA.

Elaine said: “We are very much looking forward to hosting what is set to be an instructive, insightful workshop on 23 October.

“We expect them to be of interest to manufacturers of all experiences and sizes who recognise that having the right knowledge when negotiating compliance with a new medical device in any given country is an absolute essential if they are to achieve success there.

“Our focus will be on understanding the significant requirements for US regulatory processes if they are to overcome challenges while opening up fresh opportunities for their commercial ambitions.

“In order to do that, the workshops will offer real world examples, bringing to life what a manufacturer needs to know when considering their strategy for entering the US market with a new medical device.”

She added: “Joining the workshops will also 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.

“Fundamentally, a strong understanding of regulatory compliance – preparing for it, navigating it and then maintaining it – must be intertwined with the development process early on when attempting to harness the true potential of new innovations.”

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.

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. He is also Associate Principal for Impact at Heriot-Watt University.

Edwin has extensive experience of working in the Life Sciences and Medical Devices/IVD Industry for over 20 years and has proven 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.

Edwin also currently lectures at University of Strathclyde and Glasgow University on medical device regulations.