Who Should Enroll:
Regulatory affairs professionals in charge of labeling, developmental engineers and clinical research managers who contribute to the setup of medical device labeling, and quality managers and engineers who are responsible for change control of technical documents (including labeling) are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
A strong comprehension of the pre-market notification (510k) and pre-market approval process for market access in the US is required. Knowledge of the principles of risk management processes, including human factors, engineering requirements, and impacting labeling is also required for this course.
For more information on the topics above, please review the following courses:
- Risk Management for Medical Devices in EU and US (ID 77)
- US FDA 510(k) Notification Process (ID 92)
- US FDA Investigational Device Exemption (IDE) Overview (ID 121)