Senior Manager - Quality, Standards & Regulations
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 and on New Technologies. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industry. Koen has been chairing COCIR’s Software Focus since 2009. Today Koen’s focus is mainly on regulations and standards affecting adaptive intelligence, machine learning, the responsibilities of app stores and the quality and reliability of health software.
Koen 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.
With regards to software standards Koen contributes to the development of IEC 82304 on safety, quality and reliability of health software and IEC 62304 on software lifecycle processes.
Friday, May 7, 2021
08:45 – 17:00 CEST
Tuesday, May 11, 2021
13:30 – 14:00 CEST