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Koen Cobbaert

Presenter

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.

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 and New Technologies 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). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). 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 a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).

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.

Koen Cobbaert’s courses

Reviews for Koen’s courses

Loved it! I wouldn't change a thing! I wish I had attended this course sooner. I wanted a practical approach for complying with the EU AI act. [Speaker] did a fantastic job delivering on this topic — his knowledge of the subject matter is outstanding. I'd wholeheartedly recommend this course to other regulatory professionals.

4 Apr 2025

Masterclass: Market Authorisation of AI-enabled Medical Devices

Overall this course was excellent, and I found it extremely useful. I would highly recommend it. I wanted to understand the processes for developing compliant medical device software. I definitely got the necessary information to understand this better. Both excellent speakers and clearly extremely knowledgeable on the subject matter. Very impressive. I thought it would focus more on the development process (e.g. detail around how to implement EN 62304), but what this course demonstrated was that there is a lot more to consider. So that was a useful learning experience as well.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

It was really good, both speakers tried to keep the audience attention with interactive tasks. As an overall view I am satisfied with the webinar and with the provided training materials, both with the shared information and the information quality.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

[Speakers had] huge expertises. I accomplished what I wanted to achieve from this course.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Both speakers extremally knowledgeable and fantastic teachers. thoroughly enjoyed the course! Fantastic all around!

22 Jul 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Extremely knowledgeable and capable presenters with very informative and well delivered content.

11 Dec 2023

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

A lot of information covered areas outside of scope of work but I found it very informative and gave me a good understanding of the entire lifecycle of a medical device.



24 Apr 2023

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

This course contained excellent content and speakers. I enjoyed that it was interactive with case studies and quiz exercises to keep engagement up and check understanding.

17 Oct 2022

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Overall I am satisfied. Well organized and good quality of speakers and materials

17 Oct 2022

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Very good webinar in term of content, presentation and speakers. Lots of extra material made available by the presenters

17 Oct 2022

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

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