IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 4 - General Requirements

IEC 62304:2015 Medical Device Software Lifecycle Processes IEC62304-4.3: Software Safety Classification

Assign software safety class A, B, or C based on possible harm contribution and document the rationale.

Other controls in Clause 4 - General Requirements

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