Niamh St John Lynch
Biography
30-year's experience in Life Science Industry, Pharma, IVD and Medical Devices. Engineering, Quality and Regulatory hands-on experience and leadership of strategic regulatory pathway to market for SaMD/SiMD and AI-enabled Medical Devices. Leader and author of regulatory requirements including IEC 62304 and IEC 63450. Chair of TC10 Medical Equipment, Systems and Software for Ireland. Member of IEC SNAIG and EU's CEN-CENELEC Task 2 AI advisory committees. Part-time lecturer of Medical Device Software Validation and Embedded Systems.
Teaching
MSc in Computing in Medical Device Software Engineering
Qualifications & Awards
BSc (Hons) Cognitive Science / Artificial Intelligence, UK
MSc Organisational Psychology, UL, Ireland
MSc Neuropharmacology, NUIG, Ireland
MScSED Software Engineering and Database Technologies, NUIG & Regis University USA
Postgraduate Diploma TechInnovate, NUIG Ireland
PhD Candidate, DkIT in collaboration with UCD, AIeMD Regulatory Requirements for Healthcare
Research & Interests
Artificial Intelligence-enabled Health Software and Medical Devices. Software Engineering for Healthcare. Trustworthy AI in Healthcare. Software as a Medical Device and Software in a Medical Device. Healthcare International and European Regulatory Standards Development.
Publications
The publications listed below represent my 2 most recent works as recorded on ORCiD
2026
DOI: 10.1007/978-3-032-04288-0_5
Type: Book chapter
2024
DOI: 10.1007/978-3-031-71139-8_8
Type: Book chapter