Regulated Software Research Centre >> People >> Niamh St John Lynch

Niamh St John Lynch

Niamh St John Lynch is a PhD Candidate for Regulatory Requirements of Artificial Intelligence-enabled Medical Devices at DkIT, Regulated Software Research Centre.  Awarded MSc Organisation Psychology, UL, MScSED Software Engineering and Database Technologies and MSc Neuropharmacology, NUIG.  PostGrad Diploma for TechInnovate, an engineering branch of BioInnovate, utilising the same methodologies from Stanford University for Needs Analysis and Design to Funding & Start-up.  BSc (Hons) Cognitive Science (Artificial Intelligence) from University of Hertfordshire UK (1998), leading to Systems Engineer role with EDS, Europe.

25+ Years’ Life Science experience and leader of 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.  Recipient of J&J award for delivering Risk Management integration with Change Management within J&J family of companies in compliance with ISO 14971. 

Ex-Notified Body Certification Officer with NSAI, having lead role as technical reviewer of Active Medical Devices and Software, including to the requirements of ISO 62304 and ISO 60601 family of standards.

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