Regulatory Writing: Medical Device Submissions
TCC6370 / 4 q.h.
Formerly PW 3398.
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.
|
