DkIT researchers present on data breaches and AI-enabled devices at major events
DkIT Researchers in the Regulated Software Research Centre, Mugdha Srivastava and Niamh St John Lynch were recently invited to present their research at events in Technological University Dublin (TUD) and The Radisson Hotel Limerick.
Mugdha Srivastava was invited to present her research at the inaugural Women+ in Early Career Research Symposium at Technological University Dublin, held to celebrate International Women’s Day, while Niamh St John Lynch was invited to present at the Irish Medtech Quality and Regulatory Forum held in Limerick.
The Women+ in Early Career Research Symposium at Technological University Dublin, was held to celebrate International Women’s Day. The event brought together early-career researchers from across Ireland spanning disciplines from STEM and health sciences to humanities, creative practice, and social sciences, and featured presentations and posters from 20 researchers, along with a keynote address by Dr Ebun Joseph. This inaugural event aimed to create a supportive and inclusive space to showcase research, encourage cross-disciplinary dialogue, and strengthen professional networks among early-career researchers. Mugdha used this symposium to share her research findings on how data breaches, such as the HSE Breach in 2021, impact the lives of regular people and change their trust levels in institutions. The event was a great opportunity to connect with other researchers at similar stages of their academic careers.
The Irish MedTech Quality & Regulatory Forums represent important face-to-face networking events for QA/RA specialists and leaders in the MedTech sector in Ireland.
The Forum agendas are developed based on feedback from the Irish MedTech member companies and in conjunction with the members of Irish MedTech Regulatory Steering Committee and the Task Forces including the Digital Health Task Force, which Niamh St John Lynch of the Regulatory Software Research Centre from DkIT, is a member. Industry specialists from across Irish Medtech member companies and invited expert national and European speakers (including Notified Bodies/ Competent Authorities etc.) guide Forum participants through topics of interest.
Over the last number of years, the area of focus has been the implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The Digital Health Task Force have been concerned with the emergence of Software as a Medical Device (SaMD) and more recently Artificial Intelligence technologies, Machine Learning, including risks and opportunities arising from these.
Niamh St John Lynch presented the FDA’s Pre-Determined Change Control Plan in 2025 and this year on 5 March 2026, presented the important topic arising from the Simplification Digital Package and Omnibus published by the European Commission on 16 December 2025. This proposal simplifies the MDR/IVDR in a number of ways following calls from industry to improve innovation, device availability and lesson the heavy regulatory burden. It calls for single regulatory framework for AI-enabled Medical Devices (AIeMD). Companies have reported ceasing to implement the AI Act Regulation (AIA) 2024/1689 with widescale confusion in Europe as to whether the AIA is required at all. Niamh presented the proposal and the EC’s intention from moving MDR/IVDR from Annex I Section A to Section B and clarified the requirements that are expected to prevail (Articles 8-15), and supported by the MDCG-2025-6 Guidance.
