ISO 13485 a complete guide to quality management in the medical device industry
by
 
Abuhav, Itay.

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

Author
: 
Abuhav, Itay.

ISBN
: 
9781439866122

Publication Information
: 
Boca Raton : CRC Press, 2012.

Physical Description
: 
xiii, 361 p. : ill.

Contents
: 
ch. 1. Scope -- ch. 2. Normative references -- ch. 3. Terms and definitions -- ch. 4. Quality management system -- ch. 5. Management responsibility -- ch. 6. Resource management -- ch. 7. Product realization -- ch. 8. Measurement, analysis, and improvement.

Abstract
: 
"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.

Subject Term
: 
Medical instruments and apparatus -- Standards -- Handbooks, manuals, etc.
 
Medical instruments and apparatus industry -- Quality control -- Standards -- Handbooks, manuals, etc.

Electronic Access
: 
Distributed by publisher. Purchase or institutional license may be required for access.


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book290775-1001ONLINEElektronik Kütüphane