Doctoral research at DkIT gives rise to a new international standard for AI in medical devices
Research from the Regulated Software Research Centre (RSRC) at Dundalk Institute of Technology has led directly to the creation of a new international standard for the global medical device industry.
The peer-reviewed research by Niamh St John Lynch, Martin McHugh, Róisín Loughran and Fergal McCaffery, together with Dominik Kowalski of Brainlab SE was published in the AICS 2025 proceedings by Springer. The research explored the use of pre-trained artificial intelligence (AI) models in medical device software. The study found that these third-party AI models are not fully covered by existing industry standards and identified what should be assessed to ensure they are used safely, responsibly and ethically.
As part of the research, the team surveyed 44 medical device professionals. The results showed that only 30% were aware they were already using pre-trained AI models, and there was no clear agreement on how these models should be classified. The findings highlighted a need for greater clarity and guidance across the industry.
This need is now being addressed through the development of a new international standard, IEC 63767, Evaluation of Pre-trained AI Models for Use Within a Medical Device. The project will be led by RSRC doctoral researcher Niamh St John Lynch and developed by experts from around the world through IEC TC62 Working Group 17, beginning in September 2026.
The project demonstrates how research at DkIT can deliver real-world impact, helping to shape international standards that support the safe adoption of new technologies in healthcare. This research was supported by Research Ireland through the Reg-Fr-AIMs project (ID 21/FFP-A/9255).
Speaking after the announcement, Niamh St John Lynch said:
“I am very proud of the work we do in RSRC, helping to identify gaps in medical device standards and having the ability to bring these to the Advisory Groups at the highest level of IEC International Standards is incredible and then being able to directly contribute to the content of the standards based on our research is a considerable contribution to regulators and the medtech industry. I now have the opportunity to share this at the next RAPS Conference in Charlotte, USA in September this year, which is the biggest Regulatory conference in MedTech. This is the primary reason I wanted to do my PhD with DkIT and I was allowed the freedom to make a difference with the necessary oversight and infrastructure in place to be successful – thank you Dr. Loughran, Dr. McHugh and Prof. McCaffery.”
