Design Controls for the Medical Device Industry

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Book 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.

Product Details

Hardcover: 254 pages
Publisher: CRC; 1 edition (September 20, 2002)
Language: English
ISBN-10: 082470830X
ISBN-13: 978-0824708306
Product Dimensions: 8.8 x 6.4 x 0.7 inches


http://rs138.rapidshare.com/files/37846246/082470830X.rar