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Dr Fergal Mc Caffery is a Science Foundation Ireland (SFI) Principal Investigator. He is a Senior Lecturer in the Department of Visual and Human Centred Computing within DkIT. He is Director of the Regulated Software Research Centre (RSRC) in Dundalk Institute of Technology and the Medical Device Software Engineering competency area leader in Lero. He has been awarded over €14 million in funding including SFI funding through the Stokes Lectureship, Principal Investigator, CSET and Centres Programmes to research the area of medical device software. Additionally, he has received H2020, EU FP7 research funding to improve the effectiveness of embedded software development environments for the medical device industry. He also has received Enterprise Ireland Commercialisation funding for a number of different medical device projects. Recently he has also received funding for two DTIF projects. 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. Additionally, he represents Ireland at International medical device software standards meetings and is an active member of the IEC SC62A JWG7 working group that is responsible for the International standard for medical device software lifecycle processes (IEC 62304) and also the IEC SC62A JWG7 working group that is responsible for the development of a new International standard for Healthcare Software (IEC 82304). In this last few years his research group have taken been the lead authors of 4 new international ISO/IEC technical reports in the areas of medical device safety, security and risk management for medical IT Networks. In this capacity he played a leading role in the development of IEC/TR 80002-3 that was published in May 2014. He was listed as a finalist in the Irish Software Association’s Outstanding Academic Achievement Awards Category in 2014. He is also a member of the ISO SC7 WG10 working group that is responsible for the International Standard for Software Process Assessment (ISO/IEC 15504). He is also involved in spinning out 2 companies from the RSRC. He has also been appointed to an advisory committee for medical devices by the Minister for the Department of Health until the end of 2020.