Design Controls for the Medical Device Industry - Couverture rigide

Teixeira, Marie B.; Bradley, Richard

 
9780824708306: Design Controls for the Medical Device Industry
Couverture rigide
ISBN 10 : 082470830X ISBN 13 : 9780824708306
Editeur : Marcel Dekker Inc, 2002

Synopsis

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.

    • Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

    Présentation de l'éditeur

    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.

    • Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

    Éditeur
    Marcel Dekker Inc
    Date d'édition
    2002
    Langue
    anglais
    ISBN 10 
    082470830X
    ISBN 13 
    9780824708306
    Reliure
    Relié
    Nombre de pages
    260
    Coordonnées du fabricant
    non disponible
    Personne responsable
    non disponible

    Autres éditions populaires du même titre

    9780815365525: Design Controls for the Medical Device Industry, Third Edition

    Edition présentée

    ISBN 10 :  0815365527 ISBN 13 :  9780815365525
    Editeur : CRC Press, 2019
    Couverture rigide