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- Author: Brendan Cooper
- Publisher: CreateSpace Independent Publishing Platform
- Year: 2017
- Pages: 130
- ISBN-10: 1545382379
- ISBN-13: 9781545382370
- Format: 15.2 x 22.9 x 0.7 cm, softcover
- Language: English
- SAVE -10% with code: EXTRA
ISO 13485 - the Quality Management System for Medical Devices (e-book) (used book) | bookbook.eu
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Description
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.
EXTRA 10 % discount with code: EXTRA
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- Author: Brendan Cooper
- Publisher: CreateSpace Independent Publishing Platform
- Year: 2017
- Pages: 130
- ISBN-10: 1545382379
- ISBN-13: 9781545382370
- Format: 15.2 x 22.9 x 0.7 cm, softcover
- Language: English English
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.
Reviews