IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.2.1: 5.2.1 Define and document software requirements from system requirements

For each software system of the device, software system requirements are defined and documented from the system-level requirements. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 5: software development 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.

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