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PM-012MediumProviderDetective

Post-Market Monitoring System Validation

Providers must periodically validate that the post-market monitoring system is operating correctly and capturing the data necessary to detect performance issues in a timely manner, including end-to-end testing of the data collection and alerting pipelines.

Articles:Article 72(3)Annex IX

Evidence Examples

  • Monitoring system validation test report
  • Alert pipeline test results
  • Coverage gap assessment

Standards

ISO 42001:2023 §9.1Annex IX EU AI Act

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Post-Market Monitoring System Validation (PM-012) | AZComply Controls