ISO 13485
Subtitle: a complete guide to quality management in the medical device industry
By: Itay Abuhav
Publisher: Taylor & Francis; CRC Press
Published: 2012
Place of publication: Boca Raton
Language: eng
Number of pages: 361
ISBN-13: 9781439866115
Subjects: Medical instruments and apparatus; Medical instruments and apparatus industry; Equipment Design; Manufactured Materials; Handbooks, manuals; Standards; Equipment and Supplies; Quality control; Quality Control
Description: "The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.
Notes: Includes bibliographical references and index.
Table of contents: title: Scope; title: Normative references; title: Terms and definitions; title: Quality management system; title: Management responsibility; title: Resource management; title: Product realization; title: Measurement, analysis, and improvement.