QS Regulation 11: Application and Inspection of QS Regulation Requirements

The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course is the eleventh and final course in a series of Quality System (QS) Regulation courses. Topics in this course include: Key Terms, Seven Subsystems, Subsystems and QSIT, and Learn More. After completing this course, leaners will be able to recognize the application and inspection of Quality System Regulation requirements within a medical device manufacturer’s quality system.

After this course learners will be able to recognize the application and interrelationship of qs regulation requirements within a medical device manufacturer’s quality system. identify the basic concepts of the quality system inspection technique (qsit), which is the inspection process currently used by the fda to conduct level 2 baseline (comprehensive) quality system inspections.