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 02
CRN 70117
Session Fall 2016, Full-Term Session
Class Meeting Dates 09/19/2016 to 12/17/2016
Instructor Mr. Joel Kent
Schedule Tuesday 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 70621
Session Fall 2016, Full-Term Session
Class Meeting Dates 09/19/2016 to 12/17/2016
Instructor Ms. Lisa Crockett
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 70118
Session Fall 2016, Full-Term Session
Class Meeting Dates 09/19/2016 to 12/17/2016
Instructor Plinio DeGoes
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 70119
View Syllabus Download
Session Fall 2016, Full-Term Session
Class Meeting Dates 09/19/2016 to 12/17/2016
Instructor Ms. Kathy Reddig
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Fall Undergraduate
    Sep 6, 2016 (15- and 7 1/2-week classes)
    Oct 26, 2016 (7 1/2-week classes)
  • Fall Graduate
    Sep 19, 2016 (12- and 6-week classes)
    Oct 31, 2016 (6-week classes)

Academic Calendar

Talk to an Enrollment Coach

We can walk you through your program options and the application process.

 

Call Toll Free:
877.668.7727
Email:
Contact Us
©