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

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.
ASIN: 1545382379
VSKU: BVV.1545382379.G
Condition: Good
Author/Artist:Cooper, Mr Brendan
Binding: Paperback
Note: Any images shown are stock photographs and product may differ from what is shown.
Condition Notes: The item shows wear from consistent use, but it remains in good condition and works perfectly. All pages and cover are intact including the dust cover, if applicable . Spine may show signs of wear. Pages may include limited notes and highlighting. May NOT include discs, access code or other supplemental materials.