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Medical Devices

QS Regulation 9: Records

About the Course

The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This regulatory compliance course, the ninth in a series of Quality System (QS) Regulation courses, focuses on Records (21 CFR Part 820 Subpart M). Topics include key terms, general requirements, Device Master Records, and investigations. After completing this online learning course, you will be able to identify a manufacturer’s responsibilities relative to the records requirements of the QS Regulation.