Items where Author is "St John Lynch, Niamh"

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2026) Design and Expert Validation of an AI Change Management Process (AI-CMP) Assessment for AI-Enabled Medical Devices: Towards Agentic AI Change Management with Human Oversight. Design and Artificial Intelligence. ISSN 3050-7413

Muaz, Muhammad and Janjua, Zaffar Haider and Loughran, Roisin and St John Lynch, Niamh (2026) A Framework for LLM-Guided and ISO 5338-Aligned Data Engineering in Medical Device Adverse Event Reporting. In: 22nd International Conference on Artificial Intelligence Applications and Innovations, 16 – 19 July, 2026, Chania - Crete, Greece.

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2026) Aligning the AI Act and the MDR/IVDR: What the AI Act simplification proposal means for AI-enabled medical devices. Journal of Medical Device Regulations, 23 (2). pp. 57-64.

St John Lynch, Niamh (2026) Trustworthy AI in Healthcare. [Teaching Resource] (Unpublished)

St John Lynch, Niamh (2026) EC's Proposal for Simplification of EU MDR/IVDR Regulation in relation to the EU AI Act 2024/1689. In: QA/RA Regulatory Forum by Irish MedTech, 05 Mar 2026, Limerick, Ireland. (Submitted)

St John Lynch, Niamh and Mc Hugh, Martin and Loughran, Roisin and McCaffery, Fergal (2026) Agentic AI for Change Management: A Case Study of the AI Change Management Process Assessment for Medical Device Manufacturers. Design and Artificial Intelligence. (Submitted)

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2025) Evaluating Pre-trained 3rd Party AI Models in Medical Device Software Development for Responsible and Ethical Use. In: 33rd International Artificial Intelligence and Cognitive Science (AICS) 2025, 1-2 Dec 2025, DCU, Dublin. (In Press)

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffrey, Fergal (2025) Trustworthy Artificial Intelligence in Healthcare: a proposed framework. In: EuroSPI'25, 16 Sept 2025, Riga, Latvia.

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2025) Trustworthy Artificial Intelligence in Healthcare: a proposed framework. In: Systems, Software and Services Process Improvement. CCIS, 2657 . Springer Nature, Switzerland AG, pp. 69-90. ISBN 10.1007/978-3-032-04288-0_5

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and Fergal, McCaffery (2024) Artificial Intelligence-Enabled Medical Device Standards: A Multidisciplinary Literature Review. In: EuroSPI'24, 4-6 Sept 2024, Munich, Germany.

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal Artificial Intelligence Change Management Process Assessment. [Artefact]