Scotland's growing band of medical device and medical software innovators are being offered help to understand what they need to get design verification and validation – an essential step to prove to regulators and future customers that what they aim to bring to market actually works.

The Validation of Medical Devices online session on Tuesday of next week is being led by InnoScot Health, the organisation that works in partnership with Scotland's NHS to identify, protect, develop and commercialise healthcare innovations that will improve patient care.

The webinar is being co-hosted by Heriot-Watt University's Medical Device Manufacturing Centre (MDMC) and led by InnoScot Health’s Head of Regulatory Affairs, Elaine Gemmell and the Managing Director of Test Labs, Tautvydas Karitonas.

Validation is essential to ensuring any new medical or HealthTech device, or software, is safe for use and will work correctly for all patients.

The process involves confirming effectiveness and proving that a given invention meets predefined requirements such as its functional specifications, regulatory requirements, and user needs.

Ms Gemmell said:

“The webinar will spotlight design verification and validation for medical device development within an ISO 13485:2016 framework. The importance of fully understanding both, including the differences between them, cannot be understated.

“Likewise, successful planning and managing verification and validation activities throughout the entire design cycle will be discussed too.

“Case studies highlighting common issues will also be presented in order to bring them to life.”

She added the webinar is there to support people from across research, healthcare and small or medium enterprises:

“Fundamentally, this webinar will help SMEs, healthcare professionals, and researchers to develop medical devices faster so that a higher uptake of innovative medical devices can be achieved within care settings. We hope you can join us to hear more.”

Ms Genmell joined InnoScot Health, formerly Scottish Health Innovations (SHIL), in 2002 and helped establish the organisation. With more than 20 years’ experience in medical device development, she is a certified Lead Auditor in ISO 13485 /ISO 9001 and has experience of regulatory approval and CE, UKCA marking for medical devices.

Joining SHIL spin-out company, Clear Surgical, as a Director, Head of Regulatory Compliance and latterly Chief Operating Officer, she helped to establish the company with ISO 13485 accreditation and launch two innovative devices onto the market.

Last year, InnoScot Health and Heriot-Watt’s MDMC announced a five-year collaborative partnership which aims to fast-track innovation in medical and healthcare technologies and better understand clinical and nursing needs in Scotland.

Tautvydas Karitonas has an engineering background with a decade of experience developing state of the art products for healthcare, which are now used in hospitals worldwide. He is a Managing Director at Test Labs, a medical device contract research organisation, where he focuses on accelerating access to the market for medical devices.

Mr Karitonas is an active member of standards development organizations and is passionate about developing validation methods in the face of the 4th industrial revolution. With his BSc and MSc degrees in Mechanical Engineering, his knowledge links product design and development process with device verification and validation. He used his experience in hydrogen peroxide and UV-C light technologies development to influence the design of the laboratory to accelerate research timelines. 

The meeting is taking place on Tuesday 25 April from 1-2.15pm and registration is through Eventbrite

Read More: Innovation key to improving NHS Scotland, say staff; HealthTech losing faith in UK market?; Insight: Device makers urged not to mark time.

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