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BMEN.5040 Medical Device Development Regulation

Id: 041757 Credits Min: 3 Credits Max: 3


A comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements. Detailed analysis of quality assurance issues and regulatory reforms implemented under the Food and Drug Administration. Provides a step-by-step guide though the Center for Devices and Radiological Health (CDRH) investigation device exemptions, premarket approval, 510(k) application process and product development protocol and review process.

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