QARA forum, Radisson Blu, Limerick

QARA Forum Agenda

10 July 2025 | Radisson Blu, Limerick

8:30 – Registration open and networking breakfast

9:30 – Forum opening address and medtech sector development update

• Emer Sherry, Senior Executive - Irish Medtech
• Mairead Twomey, Chair of QARA Forum, Senior Director Regulatory Affairs - Stryker

9:50 – US FDA TaskForce update

• Elaine O’Connor, Regulatory Affairs Director – Medtronic

10:00 – Notified body update - BSI Group

• Sheila Walsh, Associate Head of Clinical Compliance - BSI Group

10:45 – Clinical Evaluation TaskForce update

• Mark Mullaney, Senior Director, Regulatory Affairs - Merit Medical

11:30 – Networking tea and coffee break

11:45 – Digital Health TaskForce update

• Padraig Maguire, Head of Quality & Regulatory Affairs - S3 Connected Health

12:30 – Digital Health survey presentation and Connected Health skills update

• Jennifer McCormack, Senior Executive, Medtech and Engineering
• Toma Pervan, Executive - Irish Medtech

13:00 – Networking lunch

14:00 – Update on the UKCA

• Claire Dunne, Principal Regulatory Affairs Specialist, UK & Ireland - Bausch + Lomb

14:45 – QMS, PMS and Audits TaskForce update

• Fidelma Sheerin, Chief Specialist, Corporate Quality - Stryker

15:30 – Closing remarks