Aug 05, 2021  
2014-2015 University Catalog 
2014-2015 University Catalog [ARCHIVED CATALOG]

BW 707 - Regulatory Writing: Medical Device Submissions

This course examines the process of writing medical device submissions. Topics covered include FDA medical device regulations, the medical device development process, and clinical study documents. Students will practice communicating complex scientific information in various documents, including investigator’s brochures, clinical trial reports, and IDE/PMA/510(k) submission components.

Prerequisites & Notes
(Prerequisite: BW 704 or permission of program director)

Credits: 3