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    Handbook of Medical Device Design

    Handbook of Medical Device Design

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

    Beskrivelse

    The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

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    Detaljer
    • SprogEngelsk
    • Sidetal794
    • Udgivelsesdato14-09-2000
    • ISBN139780824703998
    • Forlag CRC Press Inc
    • FormatHardback
    Størrelse og vægt
  • Vægt1630 g
    • coffee cup img
    10 cm
    book img
    15,2 cm
    22,9 cm

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    Body Regulation Quality Practice System Software development process Software verification Systems Directive SRS Manufacturing Medical Device Design Medical device Medical Device Regulation Institutional Review Board Premarket Notification CE Mark configuration items Class Ii Class Ii Device Functional configuration audit GHTF Design Input Requirements Device History Record Medical Device Directive Medical Device Software good OMP Quality System Regulation Regulatory Affairs Personnel Safe Medical Device Act Software Fault Tree Analysis SQAP notified SiO

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