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 7.3.2: 7.3.2 Document any new sequences of events

When a software item is used to implement a risk control measure, the item is evaluated for any new chain of events it could create leading to a hazardous situation, and such chains are recorded in the risk management file. Applies to classes B and C.

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