Device Manufacturing Review Evaluation Method

Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records reflected these processes. (Food and Drug Administration)

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Device Manufacturing Process Problem Evaluation Result

Problems with a device that can be traced back to a problem in the manufacturing and/or production process.

Device Manufacturing Deficiency Evaluation Conclusion

The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of…

Device Manufacture Date

The date (and time) on which the medical device is made.

Device Malfunction Code

A coded value specifying the defect or malfunction that occurred during use of the device.

Device Maintenance Review Evaluation Method

Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a…

Device Maintenance Problem Evaluation Result

A device malfunction or problem that occurs because the device was not properly maintained according to the instructions (e.g., maintenance may be…