Course overview
Keeping up with the rapidly evolving regulations governing AI-based medical devices can be challenging. Many AI providers face uncertainty around regulatory requirements, implementation strategies, and investment decisions, particularly for advanced applications such as dynamic task specification, grounded reporting, and patient chatbots.
This masterclass provides a practical understanding of how artificial intelligence is applied in healthcare, the evolving legislative landscape, and current regulatory best practices. Participants will learn how to define and position AI use cases, understand applicable regulatory frameworks, and prepare their organizations for future compliance requirements.
The second part of the course focuses on the European Union Artificial Intelligence Act (EU AI Act) and its implications for the medical device sector. Participants will examine the geopolitical drivers behind AI regulation and understand how the EU AI Act interacts with AI legislation in other regions.
Under the EU AI Act, many AI systems used in medical devices are classified as high-risk. These systems must meet stringent requirements for human oversight, safety, fundamental rights, robustness, and accessibility before they can be placed on the European Union market. Throughout the course, participants will gain practical insight into how the AI Act complements existing medical device legislation and what organizations should consider when implementing its requirements.
By the end of the course, participants will better understand the EU AI Act and its impact on the medical device industry, including areas where regulatory expectations are well established and where important discussions are still evolving. Participants will leave with practical knowledge to navigate the changing regulatory landscape for AI-based medical devices.
Please note: this masterclass does not cover cybersecurity of AI-based medical devices.
CPD Hours: 12
Course Content
- Day 1
- Introduction to Artificial Intelligence
- AI legislation as a global power play
- Best practices for developing AI-enabled medical devices
- Day 2
- EU Artificial Intelligence Act
- Implementing the EU Artificial Intelligence Act
- AI standards
- EU Support Structures for AI Medical Devices
- Day 3
- Real-world performance testing for AI-enabled medical devices
- Natural Language Processing Systems
Speakers
Koen Cobbaert
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.
Who Should Attend
Who should attend?
This masterclass is intended for professionals involved in the development, regulation, governance, or implementation of AI-based medical devices, including:
- Regulatory affairs managers
- Business strategists
- Product and service managers
- Project managers
- Systems analysts
- Compliance officers
- Legal professionals
- Software engineers and architects
- Data governance specialists
- Data scientists
- Biomedical engineers
- Clinical research associates
- Clinical informatics managers Safety engineers
- AI ethicists
Please note: Participants will benefit most if they have a foundational understanding of the regulatory requirements for medical devices under the EU Medical Device Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and applicable U.S. Food and Drug Administration (FDA) regulations.
