IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 7 - Software Risk Management Process

IEC 62304:2015 Medical Device Software Lifecycle Processes IEC62304-7.1: Risk Analysis of Software Contributing to Hazardous Situations

Identify software items that could contribute to hazardous situations and document potential causes including SOUP failures.

Other controls in Clause 7 - Software Risk 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.

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