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Dec 26, 2024
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RGAF 6230 - Regulatory Devices and Diagnostics Credits: (2) Typically Taught Spring Semester: 1st Block Online Description: An in-depth exploration of the origins and application of regulations relevant to medical devices and diagnostics. Medical device and diagnostic product development is covered through an organizational strategy and regulatory compliance lens. The course analyzes the design and application of clinical trial data related to the medical device and diagnostic regulatory process. Post-marketing strategy and device labeling are also covered. Pre-requisite(s): RGAF 6000 .
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