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Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)
14:40
YouTubeOpenRegulatory
Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)
We've created failure modes and risk controls (awesome!), but we actually have to link them correctly in our documentation as otherwise our efforts were in vain (painful!). So that's what we're going to do. Failure modes need to be linked to hazards, and risk controls can be linked to software requirements, software tests, or user tests. All of ...
1 views4 days ago
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