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 8.2.1: 8.2.1 Approve change requests

A configuration item placed under control is altered only after a change request has been approved; approval comes before implementation, and the plans may set different acceptance routes for different life cycle stages. Applies to classes A, B and C.

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