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> PLAS.6020
Note: This course is not available for the current semester.
Course No: PLAS.6020; Last Offered: Spring 2021;
Course Description
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.
Prerequisites & Notes
- Prerequisites:
- Special Notes:
- Credits: 3; Contact Hours: 3
Questions About This Course?
Contact the Advising Center at 978-934-2474 or
Continuing_Education@uml.edu
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