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 7.4.2: Analyse impact of software changes on existing risk control measures

What does 7.4.2 require?

Changes to the software, SOUP included, are analysed to see whether they might undermine risk control measures already in place. 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.