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Prof Fergal McCaffery

Professor Fergal McCaffery is founder and director of the Regulated Software Research Centre, and a Professor of Computing Science in Dundalk Institute of Technology (DkIT). He is the Medical Device Software Engineering competency area leader in Lero. He is a co-founder of Nova Leah (a spin out company from the Regulated Software Research Centre). Over the past few years, he has taken a part time career break to work with Nova Leah and also as Chief Scientific Officer for STATSports. He has been awarded over €16 million in research funding through highly competitive national and European funding calls to research the area of medical device software, including SFI awards of Stokes, Principal Investigator and a Lero Co-PI. He has published over 200 peer-reviewed conference and journal papers and is on the editorial board/programme committee for a number of leading software engineering conferences and journals. Winner of the SFI Enterpreneurship Award 2020, Winner of DkIT Established Researcher of the Year Award in 2017. Winner of the Lero Prize for Innovation and Entrepreneurship in 2019. Finalist for the Irish Software Association/IBEC Outstanding Academic of the year Award in 2015 & 2019. He is internationally recognised for his contributions to medical device software engineering. His research team have led the development of 5 International Standards/Technical reports for medical device software. He was the Leader for the development of IEC/TR 80002-3 for medical device software processes in collaboration with the ISO/IEC 62304 development team.  He also was appointed to the Health Products Regulatory Authority Advisory Committee for Medical Devices.