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InnoScot Health regulatory expert to help deliver webinar on medical device validation

InnoScot Health’s Head of Regulatory Affairs will be dispensing key advice on a fundamental part of the medical device manufacturing cycle during a webinar taking place later this month.

Elaine Gemmell is one of two specialists speaking at the ‘Validation of Medical Devices’ online session happening on Tuesday 25 April from 1-2.15 pm.

The Zoom webinar will be hosted by Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) with Tautvydas Karitonas, Managing Director of Test Labs, joining Elaine to discuss key aspects of medical device validation.

While the session is aimed primarily at Scottish SMEs involved in medical device development, it is also expected to be of interest to healthcare professionals and researchers.

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Validation of medical devices – a process of confirming that the medical device or software works in the way in which it was intended – is a significant element of the medical device manufacturing cycle.

Validation is essential to ensuring each device is safe for use and will work correctly for all patients. It confirms the effectiveness and proves that medical devices meet predefined requirements such as functional specifications, regulatory requirements, and user needs.

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

Elaine joined InnoScot Health, formerly Scottish Health Innovations (SHIL), in 2002 and helped establish the organisation. With more than 20 years of experience in medical device development, she is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience in regulatory approval and CE, and UKCA marking for medical devices. Joining SHIL spinout 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 - Medical Device Contract Research Organisation where he focuses on accelerating access to the market for medical devices.

Tautvydas 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, Tautvydas’ 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. He is proud of leading the Test Labs team that was successful in achieving a prestigious UKAS accreditation in less than 12 months.

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Last Updated: 19-Apr-2023