IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 7.3.1: 7.3.1 Verify risk control measures

The manufacturer verifies, and records the verification of, how every risk control measure has been implemented, and reviews each measure to see whether it could itself give rise to a new hazardous situation. Applies to classes B and C.

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