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Data Innovation for AI-enabled Medical Devices Training Course

This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.

28 February 2025
+ 9 July 2025, 12 November 2025 »

from £299

Need help?  Enrol or reserve

Course overview

Navigate the complexities of data governance in AI-based medical devices so that you can comply with evolving European regulations, fostering trust, compliance, and innovation in your projects.

Data is the lifeblood of AI-based medical devices. Still, due to an evolving regulatory landscape manufacturers and health institutions face several challenges when building a solid data governance structure that allows for trust and compliance.

The European landscape includes the AI Act, Data Governance Act, General Data Protection Regulation, Data Act, and European Health Data Space. This course offers a factual and comprehensive exploration of the most recent legislation and their intricate interplay.

This course teaches you how to harness legal complexity. It teaches the legal obligations, best practices, and standards for setting up a data governance framework that enables data innovation and the development of high-risk AI systems.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

By attending this course, you will:

  • Get up to speed on the data management obligations in the AI Act, Data Governance Act, Data Act, and European Health Data Space
  • Understand the interplay between these legislations
  • Get to grip on the activities needed to comply with these legislations
  • Identify data custodians that facilitate innovation
  • Learn best practices for setting up data governance frameworks

Who should attend?

Those responsible for ensuring compliance with data governance regulations of AI-based medical devices, including:

  • Business strategists
  • Product and service managers
  • Project managers
  • Regulatory affairs managers
  • Compliance officers
  • Legal professionals
  • Data governance specialists
  • Data scientists
  • Biomedical engineers
  • Clinical research associates
  • Clinical informatics managers of hospitals

Enrol or reserve

This course will cover:

Data governance act

  • Goal, scope, impact, and opportunities for data innovation
  • Data intermediation services
  • EU recognised data altruism organisations
  • Public sector bodies and the European Data Innovation Board
  • International transfer of data
  • Implementation timeline

European health data space

  • Goal, scope, timeline, impact, and opportunities for data innovation
  • Data for healthcare purposes and research purposes
  • EU infrastructures
  • Standards and guidance
  • Electronic health record exchange format
  • Timeline
  • Digital sovereignty

Data act

  • Goal, scope, timeline, impact, and opportunities for data innovation
  • Obligations, including switching, contracts, trade secrets, data control & traceability, data retention, interoperability
  • Disputes, fines
  • Standards and guidance
  • Implementing the Data act

AI act

  • Health data access
  • Regulatory sandboxes
  • AI Testing and Experimentation Facilities
  • Data governance obligations

State-of-the-art data governance and data management

Enrol or 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

28 February 2025

Live online

13:30-17:30 UK (London) (UTC+00)
14:30-18:30 Paris (UTC+01)
08:30-12:30 New York (UTC-05)
Course code 15445

  • GBP 299 349
  • EUR 439 509
  • USD 501 579

Until 24 Jan

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Not ready to book yet?

for 7 days, no obligation

9 July 2025

Live online

13:30-17:30 UK (London) (UTC+01)
14:30-18:30 Paris (UTC+02)
08:30-12:30 New York (UTC-04)
Course code 15446

  • GBP 299 349
  • EUR 439 509
  • USD 501 579

Until 04 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

12 November 2025

Live online

13:30-17:30 UK (London) (UTC+00)
14:30-18:30 Paris (UTC+01)
08:30-12:30 New York (UTC-05)
Course code 15447

  • GBP 299 349
  • EUR 439 509
  • USD 501 579

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.

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