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 5.3.6: 5.3.6 Verify software architecture

The manufacturer verifies and records that the architecture carries out the system and software requirements, risk control included; that it supports the interfaces among software items and with hardware; and that the device's architecture allows any SOUP items to work correctly. Tracing the architecture back to the requirements can meet the first of these. Applies to classes 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.