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 7.1.5: 7.1.5 Document sequences of events

Chains of events that the cause analysis shows might lead to a hazardous situation are recorded in the risk management file. Applies to classes B and C.

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