Regulatory Affairs for Post-Market Approval
A required course in the Regulatory Affairs & Compliance for Medical Devices Certificate Program.
Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for its intended use. Utilizing design controls practices and procedures, participants learn "design transfer" from research and development to manufacturing. Increase your knowledge on managing regulatory affairs activities for engineering design modifications, post approval studies, and after market product changes. Participants learn how to recognize the regulatory pathway for changes in labeling, manufacturing process, design, sterilization, packaging, material and vendor; changes due to customer complaints, product recall or field corrective action.
Click on "See Details" below and refer to "Special Notes" for additional section specific information.
SPRING 2025
Class Schedule
| Event | Date | Day | Start Time | End Time | Location | Room |
|---|---|---|---|---|---|---|
| Event Start | Date 3/31/2025 | Day MON | Start Time | End Time | Location Online (Access Begins) | Room --- |
| Event Synchronous Meeting | Date 4/2/2025 | Day WED | Start Time 06:30 PM | End Time 07:30 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 4/16/2025 | Day WED | Start Time 06:30 PM | End Time 07:30 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 4/23/2025 | Day WED | Start Time 06:30 PM | End Time 07:30 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 4/30/2025 | Day WED | Start Time 06:30 PM | End Time 07:30 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 5/7/2025 | Day WED | Start Time 06:30 PM | End Time 07:30 PM | Location Zoom | Room |
| Event End | Date 5/18/2025 | Day SUN | Start Time | End Time | Location Online (Access Ends) | Room --- |
Textbook not required; you will be notified if this changes.
Meet Your Instructor(s)
Special Notes
This course will host live sessions via Zoom. A device with audio and visual will be needed to participate. Synchronous sessions are highly encouraged for an interactive learning experience but are optional. Sessions are recorded and available for viewing, allowing learners to engage with the content at their convenience.
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