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 7.3.3: Document traceability

What does 7.3.3 require?

Where appropriate, the traceability of software hazards is recorded along the chain: hazardous situation to software item, software item to the specific cause in software, cause to its risk control measure, and measure to the verification of that measure. Applies to classes B and C.

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