| 2025 | AIAI | Comparison of Machine Learning and Deep Learning Models for Change of Direction Classification Using Engineered Features. | Pranay Jaiswal, Abhishek Kaushik, Fiona Lawless, Tiago De Melo Malaquias, Fergal McCaffery |
| 2025 | EuroSPI | Trustworthy Artificial Intelligence in Healthcare: A Proposed Framework. | Niamh St John Lynch, Risn Loughran, Martin McHugh, Fergal McCaffery |
| 2025 | EuroSPI | A Process Assessment Model for AI-Enabled Medical Device Software. | Gilbert Regan, Buddhika Gayashani Jayaneththi, Fergal McCaffery |
| 2025 | EuroSPI | A Review of AI Life Cycle-Related Standards to Address AI-Enabled Medical Device Development. | Karla Aniela Cepeda Zapata, Risn Loughran, Toms Ward, Fergal McCaffery |
| 2025 | GECCO | Multi-Objective Fairness Approach Using Causal Bayesian Networks & Grammatical Evolution. | Zahid Irfan, Risn Loughran, Muhammad Adil Raja, Fergal McCaffery |
| 2024 | EuroSPI | Towards the Development of a Data Security Risk Management Framework for Medical Device Software AI Models. | Buddhika Jayaneththi, Fergal McCaffery, Gilbert Regan |
| 2024 | EuroSPI | Artificial Intelligence-Enabled Medical Device Standards: A Multidisciplinary Literature Review. | Niamh St John Lynch, Risn Loughran, Martin McHugh, Fergal McCaffery |
| 2024 | EuroSPI | An Agile-Based Framework for Addressing Defects in Medical Device Software Development. | Misheck Nyirenda, Martin McHugh, Risn Loughran, Fergal McCaffery |
| 2024 | ICSoft | An Evaluation of Risk Management Standards and Frameworks for Assuring Data Security of Medical Device Software AI Models. | Buddhika Jayaneththi, Fergal McCaffery, Gilbert Regan |
| 2024 | IDEAL | Preliminary Investigation on Machine Learning and Deep Learning Models for Change of Direction Classification in Running. | Pranay Jaiswal, Abhishek Kaushik, Fiona Lawless, Tiago De Melo Malaquias, Fergal McCaffery |
| 2023 | EuroSPI | Identifying Agile Practices to Reduce Defects in Medical Device Software Development. | Misheck Nyirenda, Risn Loughran, Martin McHugh, Christopher Nugent, Fergal McCaffery |
| 2021 | ENASE | Expert Review of Taxonomy based Testing: A Testing Framework for Medical Device Software. | Hamsini Ketheswarasarma Rajaram, John Loane, Silvana Togneri MacMahon, Fergal McCaffery |
| 2021 | PERCOM | A Data Security And Privacy Risk Management Framework For WBAN Based Healthcare Applications. | Pangkaj Chandra Paul, John Loane, Fergal McCaffery, Gilbert Regan |
| 2020 | EuroSPI | Achieving Data Privacy with a Dependability Mechanism for Cyber Physical Systems. | Gilbert Regan, Fergal McCaffery, Pangkaj Chandra Paul, Jan Reich, Ioannis Sorokos, Eric Armengaud, Marc Zeller, Simone Longo |
| 2020 | EuroSPI | A Developer Driven Framework for Security and Privacy in the Internet of Medical Things. | Ceara Treacy, John Loane, Fergal McCaffery |
| 2020 | ICSoft | A Retrospective Study of Taxonomy based Testing using Empirical Data from a Medical Device Software Company. | Hamsini Ketheswarasarma Rajaram, John Loane, Silvana Togneri MacMahon, Fergal McCaffery |
| 2020 | ICSoft | Developer Driven Framework for Security and Privacy in the IoMT. | Ceara Treacy, John Loane, Fergal McCaffery |
| 2020 | MODELSWARD | Development of Health Software using Behaviour Driven Development - BDD. | Mohammad Z. Anjum, Silvana Togneri MacMahon, Fergal McCaffery |
| 2020 | MODELSWARD | Improving Multi-domain Stakeholder Communication of Embedded Safety-critical Development using Agile Practices: Expert Review. | Surafel Demissie, Frank Keenan, Risn Loughran, Fergal McCaffery |
| 2019 | EuroSPI | Analysis of Attacks and Security Requirements for Wireless Body Area Networks - A Systematic Literature Review. | Pangkaj Chandra Paul, John Loane, Gilbert Regan, Fergal McCaffery |
| 2019 | EuroSPI | A Framework for Taxonomy Based Testing Using Classification of Defects in Health Software-SW91. | Hamsini Ketheswarasarma Rajaram, John Loane, Silvana Togneri MacMahon, Fergal McCaffery |
| 2019 | EuroSPI | Evaluation of a Dependability Mechanism for Cyber Physical Systems. | Gilbert Regan, Fergal McCaffery, Jan Reich, Eric Armengaud, Cem Kaypmaz, Joe Zhensheng Guo, Simone Longo, Eoin O'Carroll |
| 2019 | ICSE | Catching up with method and process practice: an industry-informed baseline for researchers. | Jil Klnder, Regina Hebig, Paolo Tell, Marco Kuhrmann, Joyce Nakatumba-Nabende, Rogardt Heldal, Stephan Krusche, Masud Fazal-Baqaie, Michael Felderer, Marcela Fabiana Genero Bocco, Steffen Kpper, Sherlock A. Licorish, Gustavo Lpez, Fergal McCaffery, zden zcan Top, Christian R. Prause, Rafael Prikladnicki, Eray Tzn, Dietmar Pfahl, Kurt Schneider, Stephen G. MacDonell |
| 2019 | ISCC | Improving Communication in Risk Management of Health Information Technology Systems by means of Medical Text Simplification. | Silvana Togneri MacMahon, Marco Alfano, Biagio Lenzitti, Giosu Lo Bosco, Fergal McCaffery, Davide Taibi, Markus Helfert |
| 2018 | EuroSPI | A Process Framework Combining Safety and Security in Practice. | Fergal McCaffery, zden zcan Top, Ceara Treacy, Pangkaj Chandra Paul, John Loane, Jennifer Crilly, Arthur Mc Mahon |
| 2018 | EuroSPI | A Software Process Improvement Roadmap for IEC 62304: An Expert Review. | Peter Rust, Derek Flood, Gilbert Regan, Fergal McCaffery |
| 2017 | EuroSPI | A Lightweight Software Process Assessment Approach Based on MDevSPICE for Medical Device Development Domain. | zden zcan Top, Fergal McCaffery |
| 2017 | SPICE | A Proposed Approach to the Revision of IEC 80001-1 Following Annex SL. | Silvana Togneri MacMahon, Todd Cooper, Fergal McCaffery |
| 2017 | SPICE | How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE? | zden zcan Top, Fergal McCaffery |
| 2016 | EuroSPI | Situational Factors in Safety Critical Software Development. | Risto Nevalainen, Paul M. Clarke, Fergal McCaffery, Rory V. O'Connor, Timo Varkoi |
| 2016 | QUATIC | Towards Safer Medical Device Software Systems: Industry-Wide Learning from Failures and the Use of Safety-Cases to Support Process Compliance. | Marion Lepmets, Tom McBride, Fergal McCaffery |
| 2016 | SPICE | Safety Critical Software Development - Extending Quality Management System Practices to Achieve Compliance with Regulatory Requirements. | Andrzej Beniamin Bujok, Silvana Togneri MacMahon, Fergal McCaffery, Dick Whelan, Bernard Mulcahy, William J. Rickard |
| 2016 | SPICE | Investigating the Suitability of Using Agile for Medical Embedded Software Development. | Surafel Demissie, Frank Keenan, Fergal McCaffery |
| 2016 | SPICE | Agile - Is it Suitable for Medical Device Software Development? | Fergal McCaffery, Kitija Trektere, zden zcan Top |
| 2016 | SPICE | Software Process Improvement Roadmaps - Using Design Patterns to Aid SME's Developing Medical Device Software in the Implementation of IEC 62304. | Peter Rust, Derek Flood, Fergal McCaffery |
| 2015 | SAFECOMP | Towards an International Security Case Framework for Networked Medical Devices. | Anita Finnegan, Fergal McCaffery |
| 2015 | SPICE | Safety Critical Software Process Assessment: How MDevSPICE Addresses the Challenge of Integrating Compliance and Capability. | Paul M. Clarke, Marion Lepmets, Alec Dorling, Fergal McCaffery |
| 2015 | SPICE | The Development and Validation of a Roadmap for Traceability. | Gilbert Regan, Derek Flood, Fergal McCaffery |
| 2015 | SPICE | Software Process Improvement and Roadmapping - A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software. | Peter Rust, Derek Flood, Fergal McCaffery |
| 2014 | EuroSPI | A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps. | Derek Flood, Fergal McCaffery, Gilbert Regan, Valentine Casey |
| 2014 | EuroSPI | A Traceability Process Assessment Model for the Medical Device Domain. | Gilbert Regan, Mikls Bir, Fergal McCaffery, Kevin McDaid, Derek Flood |
| 2014 | ISSRE | A Security Argument Pattern for Medical Device Assurance Cases. | Anita Finnegan, Fergal McCaffery |
| 2014 | SPICE | MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software. | Paul M. Clarke, Marion Lepmets, Fergal McCaffery, Anita Finnegan, Alec Dorling, Derek Flood |
| 2014 | SPICE | A Lightweight Assessment Method for Medical Device Software Processes. | Fergal McCaffery, Paul M. Clarke, Marion Lepmets |
| 2014 | SPICE | An Agile Implementation within a Medical Device Software Organisation. | Martin McHugh, Fergal McCaffery, Garret Coady |
| 2014 | SPICE | The Development and Validation of a Traceability Assessment Model. | Gilbert Regan, Fergal McCaffery, Kevin McDaid, Derek Flood |
| 2013 | EuroSPI | Framework to Assist Healthcare Delivery Organisations and Medical Device Manufacturers Establish Security Assurance for Networked Medical Devices. | Anita Finnegan, Fergal McCaffery, Gerry Coleman |
| 2013 | EuroSPI | A Methodology for Software Process Improvement Roadmaps for Regulated Domains - Example with IEC 62366. | Derek Flood, Fergal McCaffery, Valentine Casey, Gilbert Regan |
| 2013 | ICSE | An agile v-model for medical device software development to overcome the challenges with plan-driven software development lifecycles. | Martin McHugh, Oisn Cawley, Fergal McCaffery, Ita Richardson, Xiaofeng Wang |
| 2013 | ICSR | Leveraging Reuse-Related Maturity Issues for Achieving Higher Maturity and Capability Levels. | Luigi Buglione, Giuseppe Lami, Christiane Gresse von Wangenheim, Fergal McCaffery, Jean Carlo Rossa Hauck |
| 2013 | PROFES | A Security Assurance Framework for Networked Medical Devices. | Anita Finnegan, Fergal McCaffery, Gerry Coleman |
| 2013 | SPICE | The Development and Current Status of Medi SPICE. | Valentine Casey, Fergal McCaffery |
| 2013 | SPICE | A Process Assessment Model for Security Assurance of Networked Medical Devices. | Anita Finnegan, Fergal McCaffery, Gerry Coleman |
| 2013 | SPICE | The Approach to the Development of an Assessment Method for IEC 80001-1. | Silvana Togneri MacMahon, Fergal McCaffery, Frank Keenan |
| 2013 | SPICE | Balancing Agility and Discipline in a Medical Device Software Organisation. | Martin McHugh, Fergal McCaffery, Brian Fitzgerald, Klaas-Jan Stol, Valentine Casey, Garret Coady |
| 2013 | SPICE | Investigation of Traceability within a Medical Device Organization. | Gilbert Regan, Fergal McCaffery, Kevin McDaid, Derek Flood |
| 2012 | ICSoft | Hybriding CMMI and Requirement Engineering Maturity & Capability Models - Applying the LEGO Approach for Improving Estimates. | Luigi Buglione, Jean Carlo Rossa Hauck, Christiane Gresse von Wangenheim, Fergal McCaffery |
| 2012 | ICSoft | Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304. | Valentine Casey, Fergal McCaffery |
| 2012 | SPICE | FIRST: Common-Sense Process Scopes for Starting a Process Improvement Program. | Luigi Buglione, Fergal McCaffery, Jean Carlo Rossa Hauck, Christiane Gresse von Wangenheim |
| 2012 | SPICE | Development of the Medi SPICE PRM. | Valentine Casey, Fergal McCaffery |
| 2012 | SPICE | The Gamification of SPICE. | Alec Dorling, Fergal McCaffery |
| 2012 | SPICE | Development of a Process Assessment Model for Assessing Medical IT Networks against IEC 80001-1. | Silvana Togneri MacMahon, Fergal McCaffery, Sherman Eagles, Frank Keenan, Marion Lepmets, Alain Renault |
| 2012 | SPICE | Barriers to Adopting Agile Practices When Developing Medical Device Software. | Martin McHugh, Fergal McCaffery, Valentine Casey |
| 2012 | SPICE | Traceability-Why Do It? | Gilbert Regan, Fergal McCaffery, Kevin McDaid, Derek Flood |
| 2011 | EuroSPI | How Can Software SMEs Become Medical Device Software SMEs. | Fergal McCaffery, Valentine Casey, Martin McHugh |
| 2011 | EuroSPI | Improving Verification & Validation in the Medical Device Domain. | M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman |
| 2011 | PROFES | Proposing an ISO/IEC 15504-2 Compliant Method for Process Capability/Maturity Models Customization. | Jean Carlo Rossa Hauck, Christiane Gresse von Wangenheim, Fergal McCaffery, Luigi Buglione |
| 2011 | PROFES | Building a maturity & capability model repository. | Christiane Gresse von Wangenheim, Jean Carlo Rossa Hauck, Luigi Buglione, Fergal McCaffery, Thasa Cardoso Lacerda, Ronny F. Vieira da Cruz |
| 2011 | SPICE | Challenges for Requirements Development: An Industry Perspective. | Sandra Kelly, Frank Keenan, Fergal McCaffery |
| 2011 | SPICE | Med-Trace. | Fergal McCaffery, Valentine Casey |
| 2011 | SPICE | Standalone Software as an Active Medical Device. | Martin McHugh, Fergal McCaffery, Valentine Casey |
| 2011 | SPICE | Verification & Validation in Medi SPICE. | M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman |
| 2009 | EuroSPI | Automating Expert-Defined Tests: A Suitable Approach for the Medical Device Industry? | David Connolly, Fergal McCaffery, Frank Keenan |
| 2009 | ICSE | Developing Acceptance Tests from Existing Documentation Using Annotations: An Experiment. | David Connolly, Frank Keenan, Fergal McCaffery |
| 2009 | ICSE | Improving software Risk Management in a Medical Device Company. | Fergal McCaffery, John Burton, Ita Richardson |
| 2009 | ICSoft | Preparing for Product Derivation - Activities and Issues. | Pdraig O'Leary, Ita Richardson, Fergal McCaffery, Steffen Thiel |
| 2009 | NLDB | Spreadsheet Information Retrieval through Natural Language. | Derek Flood, Kevin McDaid, Fergal McCaffery |
| 2008 | ICSE | Ahaa --agile, hybrid assessment method for automotive, safety critical smes. | Fergal McCaffery, Minna Pikkarainen, Ita Richardson |
| 2006 | ICSE | A risk management capability model for use in medical device companies. | John Burton, Fergal McCaffery, Ita Richardson |
| 2006 | ICSoft | Developing a configuration management model for use in the medical device industry. | Fergal McCaffery, Rory O'Connor, Gerry Coleman |
| 2006 | ICSoft | Mapping Medical Device Standards Against the CMMI for Configuration Management. | Fergal McCaffery, Rory V. O'Connor, Gerry Coleman |
| 2005 | PROFES | Improving the Express Process Appraisal Method. | Fergal McCaffery, Donald McFall, F. George Wilkie |