IEC 62304:2015 Medical Device Software Lifecycle Processes

Clause 8: software configuration management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 8.2.4: 8.2.4 Provide means for traceability of change

The organization keeps records linking every change request to its problem report and to its approval, with their dependencies, so that each change is traceable. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

Other controls in Clause 8: software configuration management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

8.1.1 8.1.1 Establish means to identify configuration items
8.1.2 8.1.2 Identify SOUP
8.1.3 8.1.3 Identify system configuration documentation
8.2.1 8.2.1 Approve change requests
8.2.2 8.2.2 Implement changes
8.2.3 8.2.3 Verify changes
8.3 8.3 Configuration status accounting

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MCP endpoint All IEC 62304:2015 Medical Device Software Lifecycle Processes controls