26.602 Medical Device Development Regulation

Medical Device Development Regulation

Course Details
Min Credits 3
Max Credits 3
Course ID 4296
Status Active

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 through the Center for Devices and Radiological Health (CRDH) investigational device exemptions, premarket approval, 510 (k) application process, and product development protocol and review processes.