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 8.1.3: 8.1.3 Identify system configuration documentation

The organization documents which configuration items, and which version of each, make up the configuration of the software system. Applies to classes A, B and C.

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