Regulatory Compliance Framework for Trustworthy AI Medical Device Software (Reg-Fr-AIMs)

Reg-Fr-AIMs is a Research Ireland funded Frontiers for the Future Partnership award between Dundalk IT’s Regulated Software Research Centre and UCD’s Natural Computing Research & Applications Group.

Medical devices, including software used as, or part of, a medical device, are a highly regulated technology with increasing regulatory requirements for devices with greater criticality. The levels of safety and security that must be considered for a wellness device such as a wrist worn activity tracker are considerably less than required for a life-maintaining ventilator. There is increasing potential benefit to move towards medical devices with more autonomy that can benefit from the latest advances in Artificial Intelligence research to learn and adapt, for example, in a personalised way to the individual user. However, the current medical device regulatory environment faces challenges in terms of how to handle the potential for increasing autonomy presented by Artificial Intelligence technology. This project brings together the team from Dundalk Institute of Technology who have been instrumental in defining the existing international medical device software regulatory environment with a leading team in Artificial Intelligence research from University College Dublin to develop an AI Medical Device Software framework and associated AI technologies.

The project is developing a framework to assist in making this type of Artificial Intelligence technology in medical devices to be trustworthy with safe, reliable behaviour and performance. The framework can be used by developers and medical device companies to ensure they produce safe, trustworthy and better medical devices.