Koen CobbaertChair, Senior Manager - Quality, Standards & Regulations at Philips/COCIR
Koen Cobbaert works for Philips as quality, regulatory and standards expert, specialized in health software. He also represents COCIR at the European Commission in the MDCG work groups on Borderline and Classification, New Technologies and Annex XVI devices. He has over 15 years of hands-on experience in establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions and moderating risk management and clinical evaluation for software applications in the fields of general radiology, oncology, neurology, cardiology, orthopaedics and clinical pathology. He has worked on software applications for pattern recognition, computer aided detection, reasoning engines, clinical pathways and other clinical decisions support systems, including mobile apps, embedded software and software operating in the cloud.