A UL course
This course provides high-level introduction and background regarding the compliance environment affecting the medical device industry. The course is designed to make employees aware of pertinent laws, regulations, and industry guidance that pertain to this industry. These topics are especially important because medical device product development involves close collaboration between the industry and health care professionals and the use of such devices may require the interaction and skill of medically trained personnel.
- US Food and Drug Administration (FDA) regulations
- State ethics and compliance legislation
- Foreign Corrupt Practices Act
- Federal anti-kickback laws
- Office of the Inspector General Compliance Program Guidance
- AdvaMed code of ethics
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields