IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 9 - Software Problem Resolution Process

IEC 62304:2015 Medical Device Software Lifecycle Processes IEC62304-9.5: Maintain Records

Maintain records of the analysis and resolution of each problem. Include trend analysis of problem reports to identify systematic issues.

Other controls in Clause 9 - Software Problem Resolution 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.

MCP endpointAll IEC 62304:2015 Medical Device Software Lifecycle Processes controls