3 units
- Required Courses
- Electives
Offered: Summer 2027 (not offered), Spring 2027 (unknown), Fall 2026 (unknown)
Counts toward
- Regulatory Affairs, M.S. (2026-27) - Required Courses
- Regulatory Affairs, M.S. (2025-26) - Required Courses, Electives
- Regulatory Affairs, M.S. (2024-25) - Required Courses, Electives
Introduction to regulatory affairs requirements for the medical device industry through stages of product development. FDA medical device regulations, terminology, timelines, and actual steps followed by regulatory affairs professionals. Commercial, operational, and strategic aspects of the regulatory approval process for in vitro diagnostics (IVD) and medical devices. Marketing, regulatory intelligence, risk management, and strategic considerations
From the catalog
- Grading
- LTR: Letter Graded. The class will be offered for letter grade with no option to take it for Cr/NC
- Repeatable
- 3 Maximum Credit Statement: combined credit six units of R A 773 and R A 774 applicable to a master’s degree
0 sections in Spring 2027
R A 773 is not offered in Spring 2027. Check all R A classes for other terms.