ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

2nd Edition

Itay Abuhav

CRC Press
Published May 15, 2018
Reference - 878 Pages - 50 Color Illustrations
ISBN 9781138039179 - CAT# K32964

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USD$149.95

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Features

  • Provides practical examples related to business aspects of the ISO 13485
  • Details every day cases and implimentation of the ISO 13485
  • Reviews the latest requirements in a sequential, process oriented and understandable way
  • Discusses methods from an established professional in creating an effective QMS (Quality Managemnet System)
  • Covers the design and development planning for the ISO 13485 in a pragmatic fashion

Summary

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 management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.

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