Leading regulatory expertise will be offered by InnoScot Health as part of an event held in Edinburgh next month, exploring medical device decontamination, sterilisation, and best practice in MedTech

Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) is inviting MedTech industry representatives as well as academics and researchers to attend the limited capacity in-person workshop, taking place on Wednesday 6 May.

Entitled ‘Decontamination in Medical Devices: Standards, Practice, Innovation’, the one-day deep dive event will focus on current challenges, cutting-edge solutions, and recommended approaches.

The programme has been specifically developed to support MedTech companies in understanding how decontamination considerations – a critical, multi-stage process — impact device design, manufacturing, and regulatory approval to ensure safe patient use.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell will be among speakers sharing their unique knowledge and insights from 9-4.30pm.

Her focus will be ‘Session 2: Regulatory Pathways & Standards’ from 10:30am including:

• ISO 11135, ISO 11137, ISO 17665 requirements explained
• What regulators (MHRA, Notified Bodies) expect in decontamination validation
• Key mistakes MedTech companies make in submissions

Elaine will follow Jonathan Lintott, Managing Director of Andersen Caledonia — a Bellshill-based company specialising in infection prevention and contamination control.

She said: “While the workshop is aimed primarily at companies involved in medical device development, academics and researchers are also encouraged to attend and help enrich discussion.

“The day will be a comprehensive overview of decontamination methods, the regulatory requirements involved amid a strictly regulated process, as well as real-world case studies to bring examples to life.

“Furthermore, interactivity is considered an important facet of the day, encouraging an open forum for exploring specific needs such as the key regulations which require validated processes and bespoke staff training.

“We will also highlight design considerations, risk assessment, as well as practical insights into sterilisation, packaging, and sterility assurance.”

• Register to attend

Early registration is encouraged as places are limited for room EMG83 of the Earl Mountbatten Building “to ensure meaningful discussion and interaction,” say organisers MDMC, Heriot-Watt University, and Scottish Enterprise.

Other speakers include:

• Dr Gerard Colleran and Olegs Tucs from Technical University Dublin
• Pawel de Sternberg Stojalowski, Managing Director & Founder at Aseptium
• Prof. Andrew Smith, Professor of Clinical Bacteriology at the University of Glasgow
• Michelle Black, Area Manager at Hospital Sterilisation and Decontamination Unit (HSDU) at the Royal Infirmary of Edinburgh (RIE)
• Lynsay Gracie, Head of Decontamination at NHS Greater Glasgow and Clyde (NHSGGC)

When registering, please be aware that if your category indicates that it is sold out, then you are advised to contact MDMC.

Elaine was conferred the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University in 2023.

InnoScot Health offers a skilled team of regulatory experts. Consultancy, training and advice is available to ensure awareness and compliance with legal responsibilities while supporting the design and development of products under an accredited regulatory framework.