Items where Research Centre is "Regulated Software Research Centre" and Year is 2026

Cepeda Zapata, Karla Aniela and Loughran, Roisin and Ward, Tomás and McCaffery, Fergal (2026) A Review of AI Life Cycle-related Standards to Address AI-enabled Medical Device Development. Systems, Software and Services Process Improvement. ISSN 1865-0929

Heidarpour-Shahrezaei, Maliheh and Loughran, Roisin and McDaid, Kevin (2026) Mitigating Algorithmic Bias Through Sampling: The Role of Group Size and Sample Selection. In: 6th International Workshop, BIAS 2025, and 2nd International Workshop, IR4U2 2025, 17 July 2025, Padua, Italy.

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 (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 (2026) Trustworthy AI in Healthcare. [Teaching Resource] (Unpublished)

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 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

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)