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Device Quality Control Review Evaluation Method
Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed to meet or exceed device specifications and customer expectations. (Food and Drug Administration)
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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.
Testing the device's characteristics when subjected to high or low pressure conditions.
