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 8.2.2: 8.2.2 Implement changes

The change is made exactly as the change request describes, and any activities that must be redone because of it are identified and carried out, including any changes to the safety class of software systems and items. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.