ISO 13485 - the Quality Management System for Medical Devices Audiobook By Brendan Cooper cover art

ISO 13485 - the Quality Management System for Medical Devices

Understanding Quality, Risk and Design Control

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ISO 13485 - the Quality Management System for Medical Devices

By: Brendan Cooper
Narrated by: Virtual Voice
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About this listen

 This concise book is broadly divided into 3 parts. The first part introduces the standard ISO 13485 and Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, a review 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. Biological Sciences Biotechnology Science Risk Management
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