About This Course
This course will provide the learner with an understanding of the purpose and conduct of clinical research in a commercial context and also provide information on the types of medical technology commercial research. This course will describe the role that regulatory affairs have in the medical technology industry and describe the types of regulatory approval for medical devices.
If you are interested in more than one Research Track chapter, please consider the full Advance Leadership Institute – Research Track course.
Successful completion of this course requires a score of 80% on the post-test.
**Please note that all programs require the participant to view the entire program prior to taking the final quiz and obtaining a course certificate.**
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 functions of regulatory affairs in the medical technology industry.
Chapters
Clinical Research Study Operations and Regulatory Affairs: Lessons from the Commercial Setting
Speaker Information
- George Dungan, MPhil, Med
Approved CRCE Hours
1.50
Category
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