IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 7.1.4: 7.1.4 Document potential causes

The risk management file records the possible ways in which software items might lead to a hazardous situation. Applies to classes B and C.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 7: software risk management 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.