Medical Device Development: A Regulatory Overview

RGA 6202 4 Quarter Hours
Course Level CPS - Graduate
Description Analyzes U.S. medical device development and approval requirements. Features detailed analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA), in addition to providing a step-by-step guide through the Center for Devices and Radiological Health (CDRH). Covers CDRH’s reengineering initiatives and evolving investigational device exemptions, premarket approval, 510(k) application process, and product development protocol and review processes. Provides practical, in-depth analyses on how emerging developments and trends are reshaping medical device regulation in the United States. Offers students an opportunity to demonstrate an appreciation of the subjective and interpretive aspects of the regulations and an ability to think critically about the interaction between regulatory and development processes.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 01
CRN 20120
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Anupama Gaur
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 03
CRN 20675
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Lisa Crockett
Schedule Tuesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 04
CRN 20689
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Jocelyn Jennings
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20194
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Jeremiah Kelly
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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