IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.8.3: 5.8.3 Evaluate known residual anomalies

Every known residual anomaly is evaluated to confirm it does not add to a risk that is unacceptable. Applies to classes B and C.

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