Niamh St John Lynch
Niamh St John Lynch, PhD Candidate & Lecturer, Regulated Software Research Centre
Niamh St John Lynch has 25+ Years' Life Science experience including leading Quality & Regulatory departments and teams with numerous continuous improvement projects within the Medical Device sector, including Boston Scientific, J&J, Merit Medical, Olympus and most recently, as Director of QA/RA with Atlantic Therapeutics start-up with successful transfer to Caldera Medical. Niamh is a Leader and Committee Member of Technical Standards within Medical Devices including convenor of Risk Management Standards and more recently actively engaged in development of ISO/IEC 63450 AIeMD - Methods for Verification and Validation and ISO/IEC 62304 2nd Ed, Software Development Lifecycle, and is an Expert Member of IEC-TC 62/AG SNAIG, the International Software network and AI Advisory Group. Niamh is an ex-Notified Body Certification Officer with NSAI, having lead role as technical reviewer of Active Medical Devices and Software. Niamh is currently a PhD Candidate working on the Regulatory Requirements of Artificial Intelligence-enabled Medical Devices at DkIT, Regulated Software Research Centre.