Specialties: Pre & post-market medical device, IVD and CDx specialist, Regulatory Strategy development, Regulatory Requirements and Harmonised Standards, CE marking, QMS development, Risk Management, Design Control, Technical File & Product Design Dossier development, MDD & IVDD compliance, CA and NB Liaison, 510k, PMA, IDE
CEO & Principal Consultant at ARC Regulatory Ltd.
MSc, Computer Aided Mechanical Engineering Design