Medical Device Development: A QA/Regulatory Overview

RGA 6202 4 Quarter Hours
Course Level 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.

Course Sections

Section 02
CRN 70419
Session Fall 2015, Full-Term Session
Class Meeting Dates 09/21/2015 to 12/19/2015
Instructor Mr. Joel Kent
Schedule Monday 5:50 p.m. - 7:30 p.m.
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 03
CRN 71528
Session Fall 2015, Full-Term Session
Class Meeting Dates 09/21/2015 to 12/19/2015
Instructor Ms. Anupama Gaur
Schedule Wednesday 5:50 p.m. - 8:30 p.m.
Campus Boston Main Campus
Course Format On Ground
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 70420
View Syllabus Download
Session Fall 2015, Full-Term Session
Class Meeting Dates 09/21/2015 to 12/19/2015
Instructor Ms. Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 70421
View Syllabus Download
Session Fall 2015, Full-Term Session
Class Meeting Dates 09/21/2015 to 12/19/2015
Instructor Dr. Carol Morello
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Fall Term
    Sep 21, 2015 (12- and 6-week classes)
    Nov 2, 2015 (6-week classes)

Academic Calendar

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