Medical Device Development: A QA/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. Prereq. RGA 6100.

Prerequisites

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

 

Course Sections

Section 01
CRN 90050
Session Summer 2017 CPS Quarter - Full Term
Class Meeting Dates 07/10/2017 to 09/02/2017
Instructor Lisa Crockett
Schedule Wednesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 90051
View Syllabus Download
Session Summer 2017 CPS Quarter - Full Term
Class Meeting Dates 07/10/2017 to 09/02/2017
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 70102
Session Fall 2017 CPS Quarter - Full Term
Class Meeting Dates 09/18/2017 to 12/16/2017
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 03
CRN 70496
Session Fall 2017 CPS Quarter - Full Term
Class Meeting Dates 09/18/2017 to 12/16/2017
Instructor Anupama Gaur
Schedule Wednesday, 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 05
CRN 70103
Session Fall 2017 CPS Quarter - Full Term
Class Meeting Dates 09/18/2017 to 12/16/2017
Instructor Plinio DeGoes
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 70104
Session Fall 2017 CPS Quarter - Full Term
Class Meeting Dates 09/18/2017 to 12/16/2017
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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