Medical Device Quality Systems

A required course in the Medical Device Development and an elective course in the Regulatory Affairs & Compliance for Medical Devices and Regulatory Affairs & Compliance for Pharmaceuticals Certificate Programs.

Quality Assurance in the medical device industry generally relies on similar Quality Systems throughout the world. The United States Food and Drug Administration utilizes the Quality System Regulations (QSR’s), while the European Community utilizes ISO 13485:2003. Learn what the essential elements of these various systems are, how there is a commonality between them, and how one Quality System approach can be developed to incorporate all essential requirements for complete worldwide application. A detailed analysis of these systems is presented, with particular emphasis on the FDA QSR’s. Full analysis of QSR’s and practical ‘how to’ recommendations and approaches is also presented. At the conclusion of the course, participants will be able to develop a full QSR system and will be able to understand how to modify current Company systems to comply fully with the QSR’s. Participants will also be able to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 13485:2003 as well.

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