Introduction to the Quality System Regulation (QSR)
Good Manufacturing Practices (GMPs) help protect medical devices and medical device users. This course describes the GMPs for medical devices as specified in the Quality System Regulation (QSR). Topics in this course include: Quality System, Design Control, Software Validation, and Responsibility. After completing this course, learners will be able to identify the components of a quality system, design controls, and software validation.
