This two-day course has been designed as an introductory course on the Quality System Regulation (QSR) for medical device and biotech personnel. Upon completion of this course, attendees will have gained the background knowledge necessary to understand and develop QSR compliant programs for your medical device or biotech product.Participants will have gained insight into how to prioritize QSR implementation at each stage of development and how to assess your progress.Attendees will also learn what the “deliverables” are at each stage of the development process.