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Medical Devices Tag

MAUDE: What Any Surgical Patient Needs to Read

MAUDE Manufacturer and User Facility Device Experience Database What every patient should know prior to going into surgery and if there are problems reported during your surgery. MAUDE data mandatory from the FDA represents reports of adverse events involving medical devices. The data consists of voluntary reports since...

The FDA and The Socipathic Business Model™ Case Study

The essence of good government is trust. Kathleen Sebelius From JAMA:  The Food and Drug Administration (FDA) acted without regard for employees’ whistleblower rights, according to a joint staff report released February 26 by Rep Darrell Issa (R, Calif), chairman of the House Committee on Oversight...