Koen Cobbaert
Koen Cobbaert is Quality and Regulatory Manager at Philips Healthcare. He represents COCIR in numerous work groups at European level. Koen has over 15 years of hands-on experience in establishing regulatory strategies, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software applications.
Medical Device Software: Complying with the MDR & FDA Regulations
28-30 Apr 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
The Medical Device Summer School - From Concept to CE Marking
5-9 Jul 2021
*A practical five-day course with interactive workshops - now in its 17th successful year!*
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
Medical Device Software: Complying with the MDR & FDA Regulations
27-29 Oct 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Software: Complying with the MDR & FDA Regulations
3-5 Nov 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.