IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 6: software maintenance process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 6.2.1: 6.2.1 Document and evaluate feedback

Feedback on released software, from within the organization and from users, is monitored, recorded and assessed to decide whether there is a problem. Any problem is logged as a problem report (covering both actual and possible adverse events, and departures from specification), and each report is assessed for its effect on the safety of the released software and for whether a change is required. Applies to classes A, B and C.

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