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Medical Devices

QS Regulation 2: Quality System Requirements

About the Course

The second in a series of Quality System Regulation courses, this compliance course focuses on the management responsibility, quality auditing, and personnel requirements of 21 CFR Part 820, Subpart B. The QS Regulation provides a regulatory compliance framework for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions before taking this course.