Medical Device Development: A 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 90317
Session Summer 2014, Full-Term Session
Class Meeting Dates 06/30/2014 to 08/23/2014
Instructor Dr. Irina Kulinets
Schedule Monday 5:50 p.m. - 8:30 p.m.
Campus Boston Main Campus
Course Format Blended
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 90318
Session Summer 2014, Full-Term Session
Class Meeting Dates 06/30/2014 to 08/23/2014
Instructor Dr. Irina Kulinets
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Upcoming Academic Term Dates
  • Spring Term
    Apr 7, 2014 (6- and 12-week classes)
    May 19, 2014 (6-week classes)
  • Summer Term
    Jun 30, 2014 (4-, 6-, and 12-week classes)
    Jul 28, 2014 (4-week classes)

Academic Calendar

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