IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 8 - Software Configuration Management Process

IEC 62304:2015 Medical Device Software Lifecycle Processes 8.2: Change Control

Approve changes through documented procedure including impact analysis, verification, and traceability.

Other controls in Clause 8 - Software Configuration Management Process

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.