| Health / Medical Topics |
Device Storage Problem Evaluation Result
Device problems that result from storing the device in an uncontrolled or improper environment (e.g., moisture sensitive devices stored in a humid environment). (Food and Drug Administration)
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Performing a review of the storage and shipping processes and requirements.
A device problem that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. …
Performing a review of the records and processes used to render a product free from viable microorganisms.
Verifying that the methods used to free a medical device from viable microorganisms such as fungi, bacteria, and viruses were followed. …
The process of analyzing the software code without running it. For example, formal verification, which is proving or disproving the correctness of…
Testing the device using a spectrometer or spectrograph for the dispersion of visible light (includes electromagnetic, electron, and acoustic spectroscopy).
