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Pre-Production Quality Assurance for Healthcare Manufacturers
G. William HoughDavid A. RawlingsMichael F. Turner
出版CRC Press, 1997-06-30
主題Medical / AdministrationMedical / PharmacologyMedical / GeneralBusiness & Economics / Industries / ServiceMedical / Health Care DeliveryTechnology & Engineering / Chemical & Biochemical
ISBN15749104509781574910452
URLhttp://books.google.com.hk/books?id=rvPuc37D6qcC&hl=&source=gbs_api
EBookSAMPLE
註釋The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.