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FDA Medical Device Expert

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FDA Medical Device Experts

The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness. has independent, experienced medical device experts who are familiar with the FDA’s CDRH (Center for Device and Radiological Health) 105(k) filing and safety tracking requirements of medical devices. We update our safety database from the FDA’s MAUDE (Manufacturer And User Device Experience) which houses adverse event reports from medical device manufacturers and the FDA. Our MAUDE server compiles these adverse events in sort-able, easy to understand tables which the purpose of analysis, assessing causality and for internal reporting requirements. Experienced medical device safety experts are available to carefully analyze MAUDE narratives to assess causality to a patients underlying condition versus the medical device itself. 

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