What the course covers

1. Introduction
2. Qualification and classification
3. The regulatory landscape and the clock
4. Intended purpose and requirements
5. Data governance
6. Bias, model development and evaluation
7. QMS and software lifecycle for AI
8. Risk management, robustness and cybersecurity
9. Transparency, usability and human oversight
10. Clinical evaluation and performance evidence
11. Change control and PCCP
12. Post-market monitoring and vigilance
13. Generative AI, foundation models and LLMs
14. The FDA route
15. Other markets and the international layer
16. Technical documentation and the notified body