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.

Publications

2025

Jaiswal, Pranay, Kaushik, Abhishek, Lawless, Fiona, Malaquias, Tiago, McCaffery, Fergal. 2025. Preliminary Investigation on~Machine Learning and~Deep Learning Models for~Change of~Direction Classification in~Running. In: Intelligent Data Engineering and Automated Learning {textendash} IDEAL 2024, Springer Nature Switzerland.
Jaiswal, Pranay, Kaushik, Abhishek, Lawless, Fiona, Malaquias, Tiago, McCaffery, Fergal. 2025. Comparison of~Machine Learning and~Deep Learning Models for~Change of~Direction Classification Using Engineered Features. In: Artificial Intelligence Applications and Innovations, Springer Nature Switzerland.

2020

Ketheswarasarma, H, Loane, J, MacMahon, S, McCaffery, F. 2020. A Retrospective Study of Taxonomy based Testing using Empirical Data from a Medical Device Software Company. In: ICSOFT 2020. doi: 10.5220/0009825404340442.
Armengaud, Eric, Guo, Joe Zhensheng, Kaypmaz, Cem, Longo, Simone, McCaffery, Fergal, O'Carroll, Eoin, Paul, Pangkaj Chandra, Regan, Gilbert, Reich, Jan, Sorokos, Ioannis, Zeller, Marc. 2020. Quality improvement mechanism for cyber physical systems{textemdash}An evaluation. Journal of Software: Evolution and Process, e2295. doi: 10.1002/smr.2295.
Demissie, Surafel, Keenan, Frank, Loughran, R{'o}is{'i}n, McCaffery, Fergal. 2020. Improving Multi-domain Stakeholder Communication of Embedded Safety-critical Development using Agile Practices: Expert Review. In: 8th International Conference on Model-Driven Engineering and Software Development. doi: 10.5220/0008977900490056.
Anjum,Mohammad Z, McCaffery, Fergal, Togneri Mac Mahon, Silvana. 2020. Development of Health Software using Behaviour Driven Development – BDD. In: 8th International Conference on Model-Driven Engineering and Software Development, INSTICC. doi: 10.5220/0008984201490157.
Loane, John, McCaffery, Fergal, Treacy, Ceara. 2020. Developer Driven Framework for Security and Privacy in the IoMT. In: 15th International Conference on Software Technologies. doi: 10.5220/0009828304430451.
Loane, John, McCaffery, Fergal, Treacy, Ceara. 2020. A Developer Driven Framework for Security and Privacy in the Internet of Medical Things. In: Systems, Software and Services Process Improvement, Springer International Publishing. doi: 10.5220/0009828304430451.

2019

McCaffery, Fergal, Ozcan-Top, Ozden. 2019. To what extent the medical device software regulations can be achieved with agile software development methods? XP{textendash}-DSDM{textendash}-Scrum. The Journal of Supercomputing. doi: 10.1007/s11227-019-02793-x.
Gilbert Regan, Loane, John, McCaffery, Fergal, Paul, Pangkaj. 2019. A Serverless Architecture for Wireless Body Area Network Applications. In: 6th International Symposium on Model-Based Safety and Assessment (IMBSA 2019), 239-254. doi: 10.1007/978-3-030-32872-6_16.
[Lo Bosco], Giosue, Lenzitti, Biagio, Marco Alfano., Markus Helfert, McCaffery, Fergal, Silvana Togneri MacMahon, Taibi, Davide. 2019. Improving Communication in Risk Management of Health Information Technology Systems by means of Medical Text Simplification. In: ICTS4eHealth 2019 - Part of ISCC 2019.
Loane, John, Macmahon, Silvana, McCaffery, Fergal, Rajaram, Hamsini. 2019. A Framework for Taxonomy Based Testing Using Classification of Defects in Health Software-SW91. 606-618. doi: 10.1007/978-3-030-28005-5_47.
Armengaud, Eric, Carroll, Eoin O., Gilbert Regan, Guo, Joe Zhensheng, Kaypmaz, Cem, Longo, Simone, McCaffery, Fergal, Reich, Jan. 2019. Evaluation of a Dependability Mechanism for Cyber Physical Systems. In: Systems, Software and Services Process Improvement, Springer International Publishing. doi: 10.1007/978-3-030-28005-5_33.
Gilbert Regan, Loane, John, McCaffery, Fergal, Paul, Pangkaj Chandra. 2019. Analysis of Attacks and Security Requirements for Wireless Body Area Networks – A Systematic Literature Review. In: Systems, Software and Services Process Improvement, Springer International Publishing. doi: 10.1007/978-3-030-28005-5_34.

2018

{"O}zcan-Top, {"O}, Crilly, J, Loane, J, Mc Mahon, A, McCaffery, F, Paul, P, Treacy, C. 2018. A Process Framework Combining Safety and Security: In Practice. In: European Conference on Software Process Improvement (EuroSPI). Available at: http://eprints.dkit.ie/632/1/2018McCafferyEuroSPIpost-print.pdf.

2016

Lepmets, Marion, McCaffery, Fergal, Paul Clarke. 2016. Development and Benefits of MDevSPICE{textregistered}, the Medical Device Software Process Assessment Framework. J. Softw. Evol. Process, 28, 800{textendash}816. doi: 10.1002/smr.1781.

2015

Flood, Derek, Gilbert Regan, McCaffery, Fergal, Rust, Peter. 2015. Software Process Improvement and Roadmapping {textendash} A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software. In: 15th International Conference, SPICE 201515th International Conference, SPICE 2015.