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 8.1.2: 8.1.2 Identify SOUP

For each SOUP configuration item used, including standard libraries, the title, the manufacturer and the unique SOUP designator (version, release date, patch number or upgrade designation) are documented. 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
8.1.3 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
8.2.4 8.2.4 Provide means for traceability of change
8.3 8.3 Configuration status accounting

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