ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control - Couverture souple

Cooper, Mr Brendan

 
9781545382370: ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control
Couverture souple
ISBN 10 : 1545382379 ISBN 13 : 9781545382370
Editeur : CreateSpace Independent Publishing Platform, 2017

Synopsis

This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis’ of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics or those wishing to have a physical resource.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

This concise book is broadly divided into 3 manageable parts. The first part introduces the standard ISO 13485 and the basics of Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, an overview of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis’ of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics or those wishing to have a physical resource.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CreateSpace Independent Publishing Platform
Date d'édition
2017
Langue
anglais
ISBN 10 
1545382379
ISBN 13 
9781545382370
Reliure
Broché
Nombre de pages
130
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
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