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 | | Design Controls for the Medical Device Industry (Lung Biology in Health and Disease) by Marie B. Teixeira, Richard Bradley ISBN-10: 9780824708306 ISBN-10: 0-8247-0830-X ISBN-13: 9780824708306 ISBN-13: 978-0-8247-0830-6 Hardcover 2002-09-20 CRC Find Lowest Price |
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Product Description This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to · prepare for an FDA audit · identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies · determine the compatibility of design specifications and manufacturing, installation, and servicing demands · ensure that proper design, function, and performance stipulations are understood and met · verify and validate design criteria and production schemes · eliminate confusion and prevent communication breakdowns · allocate and conserve resources · perform risk assessment analyses · predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines. | ||