Abuhav, Itay <br/><br/>
ISO 13485 :  a complete guide to quality management in the medical device industry / 
Itay Abuhav. 
 - xi, 361 pages :  illustrations ;  24 cm 
<br/><br/> Includes index. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>Scope -- Normative references -- Terms and definitions -- Quality management system -- Management responsibility -- Resource management -- Product realization -- Measurement, analysis, and improvement. 
<br/><br/> '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. 
<br/><br/><label>ISBN: </label>9781439866115  RM 530.44 1439866112 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Medical instruments and apparatus--Standards--Handbooks, manuals, etc.<br/>Medical instruments and apparatus industry--Quality control--Standards--Handbooks, manuals, etc.<br/>Equipment and Supplies--standards.<br/>Equipment Design--standards.<br/>Manufactured Materials--standards.<br/>Quality control.<br/>Equipement mico-chirurgical.<br/>Normes internationales.<br/>ISO.<br/>Contre de qualit<br/>Manuels.