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Medical Devices

QS Regulation 5: Identification and Traceability; Production and Process Controls

About the Course

This fifth in a series of Quality System (QS) Regulation compliance training focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete the previous courses in the series before taking this course.