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 Registrar’s Course Catalog for course prerequisite information.

 

Course Sections

Section 01
CRN 20131
View Syllabus Download
Session Winter 2017 CPS Quarter - Full Term
Class Meeting Dates 01/09/2017 to 04/01/2017
Instructor Lisa Crockett
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 03
CRN 20779
Session Winter 2017 CPS Quarter - Full Term
Class Meeting Dates 01/09/2017 to 04/01/2017
Instructor Stephen Amato
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 04
CRN 20797
Session Winter 2017 CPS Quarter - Full Term
Class Meeting Dates 01/09/2017 to 04/01/2017
Instructor Plinio DeGoes
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20213
Session Winter 2017 CPS Quarter - Full Term
Class Meeting Dates 01/09/2017 to 04/01/2017
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 9, 2017 (6- and 12-week classes)
    Feb 20, 2017 (6-week classes)

Academic Calendar

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