Commit to one concrete postmarket escalation trigger for potential device safety signals.
Write one postmarket escalation trigger for possible complaint, MDR, or field-action review. Use real medical-device support language such as patient harm, medical intervention, malfunction during use, wrong result, device unavailable, or customer-initiated removal from service. WHEN a report mentions __, THEN I will open/flag __, capture device identifiers, patient outcome, event timing, device availability, reporter contact, and escalation owner, then route to __ before closing the ticket. In three days, check whether the trigger was tested against three real or realistic support examples. A support ticket says a device stopped during patient monitoring and the patient received medical intervention. A…
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