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 7.2.1: 7.2.1 Define risk control measures

For every possible cause recorded in the risk management file by which a software item might lead to a hazardous situation, risk control measures are set and recorded following ISO 14971, whether the measure sits in hardware, in software, in the working environment or in instructions to users. Applies to classes B and C.

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