IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 9 - Software Problem Resolution Process

IEC 62304:2015 Medical Device Software Lifecycle Processes IEC62304-9.1: Prepare Problem Reports

When a software problem is detected, create a problem report. The problem report shall document the problem including steps to reproduce, severity, and criticality.

Other controls in Clause 9 - Software Problem Resolution Process

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