This intensive one-week course provides the basic knowledge and skills needed to develop and maintain a quality system program that conforms to the FDA's Quality System regulation. Course content is the culmination of almost two years of consensus development on the part of a respected group of more than thirty quality system experts from the Medical Device Industry. Instruction will be provided by experts in the field who were instrumental in developing the program. The course is designed for professionals directly involved in meeting FDA's Quality System requirements or those who are ultimately responsible for compliance; a basic understanding of the FDA quality system requirements, including direct work experience, is strongly recommended. An optional 2.5 hour exam will be administered on Friday to test mastery of the materials and ability to interpret the regulation correctly. Those who pass the exam will receive a certificate of achievement directly from AAMI. The registration rate includes all course materials, meals during the day, and exam/certification expenses.  Registration is limited and the course is expected to fill quickly; register online to reserve your place.