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Medical Device Quality Systems
A required course in the Certificate Programs Medical Device Development and Regulatory Affairs and Compliance.
Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.
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Course Description
Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 13485:2016. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.
Recommended prerequisite: EECS_X445.2, Regulatory Requirements for the Medical Devices 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 01/09/2023 Monday --- --- Online (Access Begins) ---
END 03/19/2023 Sunday --- --- Online (Access Ends) ---