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    Practical Design Control Implementation for Medical Devices

    Practical Design Control Implementation for Medical Devices

    Af
    Bog E-bog
    • Format
    • Bog, hardback
    • Engelsk
    • 230 sider

    Beskrivelse

    Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

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    Detaljer
    • SprogEngelsk
    • Sidetal230
    • Udgivelsesdato12-03-2003
    • ISBN139781574911275
    • Forlag CRC Press Inc
    • FormatHardback
    Størrelse og vægt
  • Vægt616 g
    • coffee cup img
    10 cm
    book img
    17,8 cm
    25,4 cm

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    Mode Engineering Industry Reliability Requirements Failure Process Planning Validation Companies CFR Design & Control Medical Device Design Medical device Design Verification Design-FMEA Design Control Requirements Design Control Guidance Design transfer Design validation Design Inputs FDA CDRH Design Control Guidelines Design Output Initial Production Units Firm’s Quality Systems Quality System Regulation Reliability Plan Reliable Medical Devices Process FMEA Safety Factors Medical Device Industry Luer Lock Weibull Plot
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