ISO 13485:2016 : a complete guide to quality management in the medical device industry /

"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality managemen...

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Bibliographic Details
Call Number:Libro Electrónico
Main Author: Abuhav, Itay (Author)
Format: Electronic eBook
Language:Inglés
Published: Boca Raton : CRC Press, Taylor & Francis, [2018]
Edition:Second edition.
Subjects:
Medical instruments and apparatus industry > Standards.
Quality control.
Quality control > Handbooks, manuals, etc.
Quality Control
Qualité > Contrôle > Guides, manuels, etc.
Médecine > Appareils et instruments > Industrie > Normes.
Qualité > Contrôle.
quality control.
BUSINESS & ECONOMICS > Industries > General.
Handbooks and manuals.
Online Access:Texto completo
Table of Contents:
  • Scope
  • Normative references
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement.

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