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 01
CRN 70467
Session Fall 2014, Full-Term Session
Class Meeting Dates 09/08/2014 to 12/06/2014
Instructor Dr. Irina Kulinets
Schedule Monday 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 02
CRN 70468
Session Fall 2014, Full-Term Session
Class Meeting Dates 09/08/2014 to 12/06/2014
Instructor Mr. Robert Ezzell
Schedule Monday 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 70469
Session Fall 2014, Full-Term Session
Class Meeting Dates 09/08/2014 to 12/06/2014
Instructor Dr. Irina Kulinets
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 70470
Session Fall 2014, Full-Term Session
Class Meeting Dates 09/08/2014 to 12/06/2014
Instructor Dr. Leslie S Schnoll
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 10
CRN 71617
Session Fall 2014, Full-Term Session
Class Meeting Dates 09/08/2014 to 12/06/2014
Instructor Dr. Leslie S Schnoll
Schedule
Saturday, Sunday
Campus Seattle Campus
Course Format Hybrid
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Class Starts
  • Summer Term
    Jul 28, 2014 (4-week classes)
  • Fall Term
    Sep 8, 2014 (6- and 12-week classes)
    Oct 20, 2014 (6-week classes)

Academic Calendar

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