Medical Device Development Regulation

Catalog Search > Engineering/Engineering Technology > 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

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