Device Pathological Examination Evaluation Method

Examining material that may have contributed to the disease or damage. Often performed using a microscope by measuring structural changes that occur along with the disease or damage. (Food and Drug Administration)

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Device Parameters

Technical specifications about a device that are issued by the manufacturer.

Device Packaging Verification Evaluation Method

Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable…

Device Packaging Problem Evaluation Result

Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents). …

Device Packaging Compromised Evaluation Result Evaluation Result

Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or…

Device Packaging Compromised

Issue associated with the non-conformance to device specifications and minimum packaging requirements as the device may not be operating and functioning as…

Device Package Insert Problem Evaluation Result

Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect…