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 7.4.1: 7.4.1 Analyse changes to medical device software with respect to safety

Every change to the software, SOUP included, is analysed to find out whether it creates new possible causes of a hazardous situation and whether further risk control measures in software are therefore needed. Applies to classes A, B and C.

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