Regulatory Writing: Medical Device Submissions

RGA 6370 4 Quarter Hours
Course Level CPS - Graduate
Description Examines the process of writing medical device submissions for regulatory agencies both nationally and internationally. Topics include device regulations, the device development process, and clinical study documents. Offers students an opportunity to practice communicating complex scientific information in various documents, including investigators’ brochures, clinical trial reports, and IDE/510k submission components.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 01
CRN 20748
View Syllabus Download
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Instructor James Luker
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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