Connect a safety risk to the control and test that address it
Coming soonS01E07 · Risk and product configuration
S01E07Video coming soon 8–12 min
The situation
What's happening
Unexpected robot motion presents a hazard that needs a traceable control and verification.
What you'll leave with
Your output
A hazard-to-control-to-verification argument with explicit gaps.
Principle
Medical-device safety risk management
Why it matters
Distinguish hazardous situation, risk control, verification and residual-risk judgment.
Check your understanding
Transfer question
Explain why a linked test might not verify the safety control.
About this episode
Who it's for
Engineering and product leaders; basic development knowledge, Ketryx knowledge taught as needed
Length
8–12 min