Walk the Risk Loop
Apply the basic medical-device risk-management loop to a concrete hazard.
The weak risk line The risk file says battery failure but does not say how a user is harmed. Without the chain, the team cannot choose the right control. ISO 14971 loop Hazard to residual risk Risk management follows a chain: identify hazards, estimate and evaluate risk, control risk, evaluate residual risk, and monitor production and post-production information. Shortcut Name hazard, add warning Risk controls that match the harm mechanism You cannot control a risk you have not described causally. Name the harm path Step 1 The hazard is battery degradation. What is the next useful risk-management move? Choose the…
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