In this course, we’ll explore global legislative trends, providing an overview of current and proposed legislation and standards applicable to AI-based medical devices while taking lessons learnt from regulatory submissions of AI-based medical devices.
The European AI Act, soon to be upon us, will redefine specific medical devices as ‘high-risk AI systems’, ensuring they are legal, ethical, safe, and robust. Our course leader will demystify this Act, revealing its intricate interplay with existing medical device regulations, empowering manufacturers to secure their portfolios and gain a competitive edge. As you conclude this session, you’ll emerge enlightened about the AI Act’s profound impact on the medical device industry, its areas of consensus and ongoing debates.
As data is the lifeblood of AI-based medical devices we’ll immerse you in contemporary data management and governance practices, aligning with standards and the proposed European Data Act and European Health Data Space.
Lastly, we’ll explore adaptive AI-based medical devices, which dynamically adapt to clinical settings or individual patients. Discover their market presence, compliance with regulations, and strategies to earn trust with authorities.
This course offers a factual and comprehensive exploration of the evolving landscape of AI-based medical devices and the regulatory frameworks that govern them.
Benefits in Attending
- Get up to speed with current regulations and standards on AI and data
- Learn best practices for the development and regulatory submissions of AI-based medical devices
- Understand the interplay between medical device, AI and data legislations
- Gain insight into how upcoming legislation might impact your company’s portfolio
- Learn how to convey in plain language how your company can comply and safeguard its product roadmaps
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Speakers
Koen Cobbaert,
PhilipsKoen Cobbaert works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys giving training and lectures and thrives on solving complex regulatory challenges.
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, New Technologies and Annex XVI devices 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). 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 delegated as Belgian expert to IEC JTC 1/SC 42 on artificial intelligence, ISO/TC 121/SC 3/JWG 12 on home respiratory equipment, ISO/TC215/JWG7 on health informatics, and to the IEC SC62A advisory group on software, networks and artificial intelligence.
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
- Global Regulatory Senior Managers
- Team Lead in Global Medical Device Management
- Principal Regulatory Affairs Specialist
- Regulatory Affairs Managers
- Safety Scientists
- Scientific Support Specialists
- Software Engineers
- Head of Product Development
- Device Technical Lead
- IT Quality Advisers
