Regulated Software Research Centre

Regulated Software Research Centre

Our Mission is to establish the Regulated Software Research Centre (RSRC) as a world leader in the development of methods and tools to assist medical device manufacturers comply with the regulatory requirements related to the development of medical device software, whether embedded within the device, standalone, or as part of a networked medical device while improving the efficiency of the medical device software development lifecycle. In recent years, this has included the safe, ethical and trustworthy incorporation of Artificial Intelligence (AI) methods and tools into the critical safety domain of medical device software. Our research is conducted in collaboration with industry partners, national agencies, the international standards community and other research centres. We are active in the development of international standards and technical reports related to medical device software development and IT networks. In addition, an educational programme provides training and graduates to address the current skills gap in the medical device software development domain in Ireland. Our Vision is to seek to foster a medical device software ecosystem in Ireland, by providing the frameworks that will allow medical device manufacturers to efficiently comply with existing regulations; providing companies wishing to make the transition to medical device software development with a clearly defined route to do so; and ensuring that sufficient knowledge is available through specialist spin-out companies and graduates equipped with required skills to support this ecosystem. 


  • RESEARCH : Advance the State-of-the-Art in Medical Device Software Development Processes
  • INDUSTRY : Work with partners in the medical device industry and international standards community to identify and solve industry problems related to the efficient development of regulatory compliant medical device software
  • COMMERCIALISATION: Develop a cluster of medical device software research companies as spin-out organisations from the RSRC.
  • EDUCATION : Attract and educate the medical device software development process practitioners, graduates, and researchers of the future. 

RSRC targets a number of areas of research as follows:

  • Medical Device Software Process
  • The incorporation of Artifical Intelligence (AI) into Medical Device Sofware
  • Trustworthy AI
  • Bias in AI
  • Mobile Medical App Development Process
  • Generic Software Process Assessment and Improvement
  • International Medical Device Standards Development
  • Agile Software Development
  • Medical Device Security and Safety
  • Software Traceability
  • Medical Devices within IT Networks
  • Medical Device Software Testing and Defects

Further details of research in these areas can be found by following the links below.