METS1035 Medical Device Quality Systems (On Hold)

This course introduces the student to aspects of medical device manufacturing quality systems that fall under federal and international regulation. The student will gain knowledge of US regulations including: Quality Systems Requirements (QSR), current Good Manufacturing Practice (cGMP), and Quality Systems Inspection Techniques (QSIT). International regulations such as ISO 13485 will also be covered. Emphasis will be placed on understanding how domestic and international regulations affect design, development, documentation, production, corrective and preventive action, and site inspection in manufacturing facilities. Students will practice proper documentation techniques and participate in mock audits.