Presented by
Management Forum
Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into MDCG guidelines, practical case studies, and regulatory frameworks.
9 July 2025
+ 12 November 2025 »
from £350
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Navigate the complexities of software classification under the Medical Device Regulation, so that you can ensure compliance and avoid regulatory pitfalls. Attend this course to gain expert insights, so that you can confidently apply the MDCG guidelines and enhance your approach to medical device software classification.
Join us for an insightful course delving into the complexities of software classification under the Medical Device Regulations. With the flawed Classification Rule 11 you need expert advice to navigate this opaque topic effectively. This course, led by a key participant in the drafting process of the Medical Device Coordinators Group (MDCG) guidance, provides invaluable context to help you read between the lines and understand the true intent behind its wording. Don’t let the convoluted language and cautious interpretations by regulators trip you up.
The course includes comprehensive case studies to solidify your understanding, allowing you to apply what you've learned to real-world scenarios. With our expert course leader's insider perspective, you will get a clear interpretation of the MDCG guidelines, ensuring you are well-prepared to navigate and apply them in your work.
We will also explore the Helsinki Procedure, a crucial framework for resolving disputes and providing guidance on challenging classification issues.
This course is part of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
By attending this course, you will:
Any professionals that are integral in navigating and applying the complex classification rules for software as a medical device (SaMD) or medical device software (MDSW) under the current regulations, including:
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
9 July 2025
Live online
09:00-12:30 UK (London) (UTC+01)
10:00-13:30 Paris (UTC+02)
04:00-07:30 New York (UTC-04)
Course code 15440
Until 04 Jun
Not ready to book yet?
for 7 days, no obligation
12 November 2025
Live online
09:00-12:30 UK (London) (UTC+00)
10:00-13:30 Paris (UTC+01)
04:00-07:30 New York (UTC-05)
Course code 15441
Until 08 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Ireland
Half-day
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: