RMS02 - Risk Management System Capabilities and Process

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