Items where Author is "St John Lynch, Niamh"

Article

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2026) A Single Regulatory Framework for AI‑Enabled Medical Devices: Implications of the EU Simplification Digital Package and Omnibus Proposal. Journal of Medical Device Regulations. (In Press)

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)

Book Section

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

Conference or Workshop Item

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 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 Fergal, McCaffery (2024) Artificial Intelligence-Enabled Medical Device Standards: A Multidisciplinary Literature Review. In: EuroSPI'24, 4-6 Sept 2024, Munich, Germany.

Artefact

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

Teaching Resource

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 [Teaching Resource] (Unpublished)