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 7.2.2: 7.2.2 Risk control measures implemented in software

If a software item's functions carry out a risk control measure, that measure is written into the software requirements, the item contributing to it receives a safety class reflecting the risk the measure controls, and the item is developed following clause 5. 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.