Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for it's 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.
||University of California, Irvine Extension
PO Box 6050
USA , 92616
UC Irvine Extension is the continuing education arm of UC Irvine. We offer programs to working adults with college degrees, seeking career advancement. Our Regulatory Affairs Specialized Studies Program gives professionals a core competency in managing the regulatory process, FDA approval process, and an understanding of the product lifecycle. Participants who complete the program will satisfy the Level I and II core competencies described in the RAPS Regulatory Affairs Professional Framework.