IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 6: software maintenance process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 6.2.4: 6.2.4 Change request approval

Any change request that would alter a released software product is evaluated and then approved. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 6: software maintenance 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.