| Health / Medical Topics |
Device Radiofrequency Induced Overheating Evaluation Result
An unacceptable or unexpected RF-induced temperature rise in the vicinity of a medical device or body part (usually caused by a closed current loop). (Food and Drug Administration)
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A defect in the processes or systems used in the design and manufacture of the device. Examples include problems within the change…
Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed…
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A device that fails when the system designed to ensure its safe operation fails.
