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Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

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

Need help?  Enrol/reserve

Course overview

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.

Benefits of attending

By attending this course, you will:

  • Examine the implementation and classification rules
  • Understand what is behind the convuluted MDCG language
  • Master the key concepts to classify medical device software
  • Learn how to apply the classification rules to real-world examples
  • Explore your options when faced with a disagreeing notified body or unfair competition 

Who should attend?

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:

  • Regulatory affairs specialists
  • Legal professionals in the medical device industry

Enrol/reserve

This course will cover:

Classification of Medical Device Software

  • Implementing rules
  • Classification rules
  • Software that drives or influences the use of a (hardware) medical device
  • Classification rule 11
  • IMDRF SaMD risk type determination
  • IMDRF SaMD risk stratification framework and its pitfalls
  • Classification rules 13, 15, and 22

Case studies - Classification

Borderline cases

  • Borderline manual on qualification and classification
  • Helsinki procedure
  • Dispute resolution and fair competition

Enrol/reserve

Koen Cobbaert
Philips Healthcare

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

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

  • GBP 350 400
  • EUR 490 560
  • USD 562 640

Until 04 Jun

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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

  • GBP 350 400
  • EUR 490 560
  • USD 562 640

Until 08 Oct

View basket 

 
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.

Run Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Live online for your team

Half-day

Typical duration

Pricing from:

  • GBP 350
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy