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 7.1.3: 7.1.3 Evaluate published SOUP anomaly lists

Where SOUP failure or unexpected results is a potential cause, the manufacturer evaluates at least the anomaly list the SOUP supplier publishes for the version used, to determine whether any known anomaly could lead to a sequence of events resulting in a hazardous situation. Applies to classes B and C.

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