Phase 5: Introduce and quality assure an AI system

The purpose of this phase is to ensure quality in the implementation process by:

  • Conducting a new risk assessment
  • Implementing necessary measures
  • Testing and validating the AI system

1. New risk assessment

2. Implement technical and organizational measures

3. Testing of the AI system

4. Clinical validation

5. Handover with operational and management plan

6. Relevant sources for phase 5

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Phase 4: Procure an AI system

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Phase 6: Operating and managing an AI system

Last update: 23. mai 2025