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Medical Devices: US Regulations

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Medical Devices: US Regulations This course is intended to provide a basic overview of US medical device regulation. It covers a wide range of issues, from the history of medical device regulation, through the steps required to submit an application to the US Food and Drug Administration (FDA) for approval (or clearance) to market a device, and finally addresses postmarket requirements. This course also discusses device classification, as well as how to select the appropriate FDA application for the device and other general device controls (including labeling, establishment registration and listing, quality system regulations, adverse event and correction and removal reporting).
List Price:$700.00
Member Price:$500.00
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