| Health / Medical Topics |
Device Bioassay Evaluation Method
Measuring the effects of a substance on a living organism. Bioassays may be qualitative or quantitative. Qualitative bioassays are used for assessing the physical effects of a substance that may not be quantified, such as abnormal development or deformity. (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.
Performing a review of the assembly and packaging processes and records for a specific device or lot that may have contributed to…
The device software performed an incorrect arithmetic operation.
