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Device Biocompatibility Testing Evaluation Method
Testing the device to determine if it elicits an undesirable local or systemic biological effect in the cells or tissues of the recipient of that device. This includes testing the device for its toxicity to cells. (Food and Drug Administration)
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A rigid, removable sheet that covers the back of a device.
Specifies whether or not the medical device is accessible for assessment by the manufacturer.
Indicates whether the device is available for evaluation by the manufacturer.
A device problem that occurred because the device was assembled or put together incorrectly.
