| Health / Medical Topics |
Device Biocompatibility Problem Evaluation Result
The device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy (see ISO 10993). (Food and Drug Administration)
YOU MAY ALSO LIKE
Measuring the effects of a substance on a living organism. Bioassays may be qualitative or quantitative. Qualitative bioassays are used for assessing…
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…
