Niamh St John Lynch
Niamh St John Lynch, Founder, CEO, St John Lynch & Co. Ltd.
Niamh St John Lynch is a PhD researcher in the regulation of AI-enabled medical devices at Dundalk Institute of Technology (registered under DCU), part of the DkIT/UCD collaborative project on Trustworthy AI-enabled Medical Devices, where she also lectures on healthcare software engineering and digital health at MSc level. She is Chair of NSAI/ETC/TC10 (Medical Equipment, Software and Systems), an expert member of IEC TC62 — including sub-team lead for AI requirements in the second edition of IEC 62304 — and a member of CEN-CENELEC's AI Act Task Groups 1 and 2. She brings more than 30 years in industry, over 25 of them in medical devices and pharma, including roles as Director of QA/RA and as a Notified Body technical reviewer and site auditor with NSAI, with earlier experience as a systems engineer. She has worked with organisations such as Boston Scientific, Johnson & Johnson, Olympus and Veryan Medical, and holds degrees in cognitive science (AI), neuropharmacology, software engineering, and organisational psychology.