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Koen Cobbaert

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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 (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

17-19 Nov 2020

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 (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

5-7 May 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 Training Course

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 (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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 (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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.