Niamh St John Lynch

PhD Candidate
Research
Department of Visual and Human-Centred Computing
PJ Carroll Building
| Room: Remote
[email protected]
+353873653571
0873653571

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

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 1 most recent works as recorded on ORCiD

2024
DOI: 10.1007/978-3-031-71139-8_8
Type: Book chapter