Have there been any changes in FDA’s approach to inspecting medical device companies?
There are several changes to FDA’s inspection approach. One important area for device manufacturers to better understand is the quality system inspection technique (QSIT) for evaluating device manufacturers’ compliance. QSIT is a “top-down” approach that focuses on key control elements or subsystems of the regulations, including management controls, design controls, corrective and preventive actions (CAPA), and process controls. Understanding this inspectional technique can help you determine the best approach to compliance for your organization. STAT-A-MATRIX has the experience and resources to guide you in this area.
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