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Regulatory Affairs for Post-Market Approval
A required course in the Regulatory Affairs and Compliance Certificate Program within the 'Device Track'.
Course Description
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.
Prerequisite: BME X412, Regulatory Affairs Planning and Management: Concept Review and Evaluation, or equivalent experience.
Instructor
Textbook Information
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 04/03/2023 Monday --- --- Online (Access Begins) ---
END 05/21/2023 Sunday --- --- Online (Access Ends) ---