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Device Assembly and Packaging Review Evaluation Method
Performing a review of the assembly and packaging processes and records for a specific device or lot that may have contributed to problems with the device. (Food and Drug Administration)
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The device software performed an incorrect arithmetic operation.
Evaluating the device for characteristics that may cause blood to clot.
The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the…
Testing the device for the presence of chemicals or other agents that do not belong on the device (contamination).
A measure (or best estimate) of the length of time during which a device existed, measured from manufacture date (and time) to…
Testing the device's response to variations in air pressure for detecting any unwanted or unintentional sound.
