IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 7.4.3: Perform risk management activities based on analyses

What does 7.4.3 require?

The relevant risk management activities of 7.1, 7.2 and 7.3 are performed on the basis of those analyses. Applies to classes B and C.

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Other controls in Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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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