| Health / Medical Topics |
Device Materials and Chemistry Problem Evaluation Result
Device malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. (Food and Drug Administration)
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Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device.
The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.
Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other…
Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records…
Problems with a device that can be traced back to a problem in the manufacturing and/or production process.
The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of…
