Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control

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

Cooper, Brendan

Paperback

Technology & EngineeringBiology

ISBN10: 1545382379
ISBN13: 9781545382370
Publisher: Createspace Independent Publishing Platform
Published: Apr 14 2017
Pages: 130
Weight: 0.40
Height: 0.28 Width: 6.00 Depth: 9.00
Language: 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.

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