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 80088
Session Spring 2017 CPS Quarter - Full Term
Class Meeting Dates 04/10/2017 to 07/01/2017
Instructor Lisa Crockett
Schedule Thursday, 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 02
CRN 80066
Session Spring 2017 CPS Quarter - Full Term
Class Meeting Dates 04/10/2017 to 07/01/2017
Instructor Lisa Crockett
Schedule Tuesday, 5:50 pm - 7:30 pm
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 80145
View Syllabus Download
Session Spring 2017 CPS Quarter - Full Term
Class Meeting Dates 04/10/2017 to 07/01/2017
Instructor Plinio DeGoes
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 80176
View Syllabus Download
Session Spring 2017 CPS Quarter - Full Term
Class Meeting Dates 04/10/2017 to 07/01/2017
Instructor Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Spring Graduate
    Apr 10, 2017 (6- and 12-week classes)
    May 22, 2017 (6-week classes)
  • Summer Undergraduate
    May 8, 2017 (7.5- and 15-week classes)
    May 22, 2017 (7.5-week classes)
    July 3, 2017 (7.5-week classes)

Academic Calendar

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