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 8.1.1: 8.1.1 Establish means to identify configuration items

The organization sets up a scheme, consistent with its development and configuration planning, that gives each controlled configuration item and each of its versions a unique identity; it covers other software products and entities as well, such as SOUP and documents. Applies to classes A, B and C.

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