Id: 041757
Credits Min: 3
Credits Max: 3
Description
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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