Formal NHS Scotland partner InnoScot Health will be part of a collaborative course taking place this month, sharing free expertise on how to successfully deliver medical device compliance in the US

An online and in-person workshop for companies aiming to navigate the specific processes of America’s Food and Drug Administration (FDA) is being run by Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) and Scottish Enterprise.

InnoScot Health’s Head of Regulatory Affairs, Elaine Gemmell, Compliance Solutions’ Principal Consultant Edwin Lindsay, and Medical Devices Technology Specialist at Heriot-Watt University, Tamer Y Cosgun, will lead the hybrid course.

Entitled FDA Regulations on Medical Devices: How to Penetrate the US Market, it will be taking place on Friday 28 November from 10am.

The deep dive workshop will be hosted on Microsoft Teams and delivered in-person at Heriot-Watt University, Edinburgh.

Following successful workshops on the same subject in previous years, the presenting organisations believe that “although there are many similarities in the regulation of medical devices in the UK, Europe and the USA, there are also some significant differences”.

They insist that discussing what a manufacturer should consider when determining strategy behind entry into the US market is vital.

Elaine — awarded the title of Honorary Professor of the School of Engineering and Physical Science at Heriot-Watt University in 2023 — said: “I am very much looking forward to being part of what is set to be an insightful, interactive course, brought to life by real world examples.

“We are welcoming manufacturers of all experiences and sizes who understand that negotiating compliance and achieving success in any given country with a new medical device is predicated on, and facilitated by, having the right knowledge.

“We can help them unlock that knowledge by sharing the significant requirements for US regulatory processes they will be required to meet in order to overcome challenges while opening up fresh opportunities for their commercial ambitions.”

She added: “Fundamentally, and when targeting any market with a new innovation, it means developing a strong understanding of regulatory compliance — preparing for it, navigating it and then maintaining it — and for it to be intertwined with the development process early on.”

In-person attendees will receive a lab tour of MDMC facilities at the end of the course.

• Register to attend

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, BEng (Hons) in Engineering and MSc in Medical Device Regulatory Affairs. Since joining InnoScot Health in 2002, she has gained more than 20 years’ experience in all aspects of medical device development and 15 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.

Tamer is a technology specialist at the MDMC and takes on technical responsibility for the success of client applications by providing provide expert advice on manufacturing and engineering coupled with insight on regulatory considerations.

He is a certified ISO 13485 internal auditor and has received certification from the Regulatory Affairs Professionals Society (RAPS) on medical devices pertaining to US FDA (510(k), PMA, De Novo) and EU MDR/IVDR (Regulation (EU) 2017/745, Regulation (EU) 2017/746). With a PhD in applied physics and a master’s degree in mechanical engineering, Tamer has extensive experience in risk management systems and complex engineering design.

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 University of Glasgow on medical device regulations.