Device Physical Structure Testing Evaluation Method

Testing the device for problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. (Food and Drug Administration)

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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…

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…