IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 9: software problem resolution process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 9.5: 9.5 Maintain records

A record is kept of every problem report, how it was resolved and how the resolution was verified, and the risk management file is brought up to date where needed. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 9: software problem resolution 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.