Lisa Donlon

Lisa Donlon is founder and director of the PraxisVerify - a secure subscription platform for the independent review and verification of life science regulatory documentation by competency-matched experts. She brings well over 20 years across clinical practice, MedTech and life sciences, with experience on both sides of the regulatory table. At NSAI (NB 0050) she rose to joint head of the EU Notified Body, the final decision-maker on EU MDR certificates. She has since used that insight in a variety of advisory projects, including to manufacturers of complex, high-risk combination products for Notified Body Opinion (NBOp) strategy, produce to submissions with the least possible pushback. She also devises innovative and comprehensive regulatory strategies for SaMD and AI-enabled devices. Lisa is an IRCA Principal Medical Device Auditor with an MSc in Pharmaceutical Technology and Regulatory Affairs. She speaks and writes regularly on AI, SaMD and the EU AI Act.