Koen Cobbaert works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys giving training and lectures and thrives on solving complex regulatory challenges.
In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification, New Technologies and Annex XVI devices and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).
In the standardization domain, Koen is delegated as Belgian expert to IEC JTC 1/SC 42 on artificial intelligence, ISO/TC 121/SC 3/JWG 12 on home respiratory equipment, ISO/TC215/JWG7 on health informatics, and to the IEC SC62A advisory group on software, networks and artificial intelligence.
Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for 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 decision support systems, including mobile apps, embedded software, and software operating in the cloud.
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An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.