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Medical Devices

QS Regulation 4: Document and Purchasing Controls

About the Course

Part four of an elearning series on Quality System Regulation (QS Regulation) focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing Controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions, QS Regulation 2: Quality System Requirements and QS Regulation 3: Design Controls before taking this course.