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 6.1: 6.1 Establish software maintenance plan

One or more software maintenance plans are set up for the maintenance process. They cover: how feedback after release is received, recorded, assessed, resolved and followed up; criteria for deciding whether feedback counts as a problem; applying the software risk management process; applying problem resolution to problems found after release; applying configuration management to modifications; and how upgrades, bug fixes, patches and SOUP obsolescence are assessed and put into effect. Applies to classes A, B and C.

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