What the course covers

1. Introduction
2. The three standards, the two regulations and the AI Act
3. The risk management system: process, plan and file
4. Intended use, misuse and characteristics related to safety
5. Hazards, hazardous situations and the techniques that find them
6. Bias as a source of hazard
7. Risk estimation, acceptability criteria and risk evaluation
8. Risk control, risks introduced by controls, and security
9. Autonomy, human oversight and information for safety
10. Overall residual risk, benefit-risk and the review before release
11. Production and post-production: the loop that closes the file
12. In vitro diagnostics: risk management under the IVDR
13. The risk management file in practice