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 8.2.3: 8.2.3 Verify changes

The change is verified, including repeating any verification the change has invalidated, taking account of the retest requirements of 5.7.3 and 9.7. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

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

8.1.1 8.1.1 Establish means to identify configuration items
8.1.2 8.1.2 Identify SOUP
8.1.3 8.1.3 Identify system configuration documentation
8.2.1 8.2.1 Approve change requests
8.2.2 8.2.2 Implement changes
8.2.4 8.2.4 Provide means for traceability of change
8.3 8.3 Configuration status accounting

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.

MCP endpoint All IEC 62304:2015 Medical Device Software Lifecycle Processes controls