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Software Risk Control Measures Implementation
Traceability connects ISO 14971 and IEC 62304.
Without it, risk control is incomplete.
Risk management only becomes meaningful when each identified risk leads to a clear, implemented and verified control measure.
ISO 14971 asks that every risk leads to a decision: reduce it, avoid it or accept it.
IEC 62304 requires those decisions to be reflected in the software and verified.
That connection from risk control measure → Safety requirement→ software requirement → implementation → test → verification is where traceability comes in.
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