Device Mechanical Problem Evaluation Result

Device problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences. (Food and Drug Administration)

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Device Mechanical Evaluation Method

Testing the device for problems that result from external forces including fluids, other objects, or environmental or physiologic influences.

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…

Device Material or Material Leachate Pyrogenic Testing Evaluation Method

Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device.

Device Material or Material Leachate Pyrogenic Problem Evaluation Result

The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.

Device Material and Chemistry Evaluation Method

Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other…

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…