ACC10 - Risk Management System capabilities and processes

Details of the RMS system capabilities:

  • Detail or upload a document detailing how known and foreseeable risks are recorded and updated throughout the AI system's lifecycle, including post-market.

  • Detail or upload a document detailing how risks are estimated and evaluated; this estimation and evaluation must consider when the AI system is used for its intended purpose as well as under conditions of reasonably foreseeable misuse.

  • Detail or upload a document detailing how other possibly arising risks are evaluated based on the analysis of data gathered from the post-market monitoring system

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