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Nov 23, 2024
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2022-2023 Undergraduate and Graduate Bulletin (without addenda) [ARCHIVED CATALOG]
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BE-GY 9763 Regulatory Issues Surrounding Medical Devices3 Credits
Medical devices are developed, manufactured, and distributed in a highly regulated environment. This course primarily concerns the processes for obtaining FDA marketing approval or clearance for biomedical devices. Prior to marketing a medical device in the United States, a specific governmental approval or clearance is required depending on the type of device and the risk associated with the device.
Prerequisite(s): Instructor and advisor’s approval.
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