ALI - Research Track: Ch 4 "Clinical Research Study Op. & Reg. Affairs: Commercial Setting" 2026
This course provides learners with an understanding of the purpose and conduct of clinical research in a commercial context, including an overview of medical technology–focused research. It also explores the role of regulatory affairs within the medical technology industry and outlines the various regulatory approval pathways for medical devices.
Authors: George Dungan, MPhil, MEd
**Please note that all programs require the participant to view the entire program prior to taking the final quiz and obtaining a course certificate.**
Approved for 1.50 CRCE Hours.
SEMINAR OBJECTIVES
> State the types of medical technology commercial research
> Understand the unique requirements for sponsored research
> Describe the high-level types of regulatory approval for medical devices
> Understand the purpose and conduct of clinical research in a commercial context
> Describe the roles, responsibilities, and function of regulatory affairs in medical technology industry