Medical Device Development Regulation

Course Search > Engineering/Engineering Technology > PLAS.6020

Course No: PLAS.6020-031; SIS Class Nbr: 13929; SIS Term: 3030
Course Status: Open

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 & Instructor

  • Prerequisites: Students with a CSCE career need permission to take Graduate Level Courses.
  • Special Notes:
  • Section Notes:
  • Core Codes: STEM
  • Credits: 3; Contact Hours: 3
  • Instructor: Christine Santagate
  • Textbook Information

When Offered & Tuition

  • Online Course
  • Spring 2021: Jan 25 to May 08
  • Course Level: Graduate
  • Tuition: $1770
  • Note: There is a $30 per semester registration fee for credit courses.

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