IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 9: software problem resolution process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 9.2: 9.2 Investigate the problem

Each problem is investigated and its causes identified where possible, its relevance to safety evaluated using the software risk management process, the outcome of investigation and evaluation documented, and change requests created for the actions needed or the rationale for taking no action documented; a problem need not be corrected if it is not relevant to safety. Applies to classes A, B and C.

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