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Medical Devices

Introduction to the Quality System Regulation (QSR)

About the Course

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 eLearning course include: Quality System, Design Control, Software Validation, and Responsibility. After completing this online training course, you will be able to identify the components of a quality system, design controls, and software validation.