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Device Quality System Deficiency Evaluation Conclusion
A defect in the processes or systems used in the design and manufacture of the device. Examples include problems within the change control, production, or quality control processes. (Food and Drug Administration)
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Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed…
Device problems that result from the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the…
A device that fails when the system designed to ensure its safe operation fails.
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to device properties.
Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to…
Medical device failure or malfunction associated with device functions, including any deviations from documented specifications, requirements, and intended uses.
