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 9.4: 9.4 Use change control process

Every change request is approved and carried out in line with the change control process set out in 8.2. Applies to classes A, B and C.

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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.

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