This essential reference acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. Medical Device Quality Assurance and Regulatory Compliance summarizes regulation activities of the FDA, the European Economic Community, and the Global Harmonization Task Force shows how to choose a standard from the ISO 9000 and ISO 14000 series teaches how to prepare your company for auditing, how to choose a notified body, and how to survive the audit reviews standards dealing specifically with medical devices such as EN 46000, ISO 13485, and ISO 13488 discusses the requirements for product submittals prior to product introduction addresses current issues such as third party approvals and more Including numerous key references, tables, and drawings, Medical Device Quality Assurance and Regulatory Compliance is ideal for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians; medical device purchasing personnel; and upper-level undergraduate and graduate students in these disciplines.