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

Price: ₹1,400.00
(as of Aug 20, 2023 03:43:20 UTC – Details)

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.

ASIN ‏ : ‎ B06ZZ1CZR4
Publisher ‏ : ‎ LifeScienceLearning.com; 1st edition (15 April 2017)
Language ‏ : ‎ English
File size ‏ : ‎ 374 KB
Text-to-Speech ‏ : ‎ Enabled
Screen Reader ‏ : ‎ Supported
Enhanced typesetting ‏ : ‎ Enabled
X-Ray ‏ : ‎ Not Enabled
Word Wise ‏ : ‎ Enabled
Print length ‏ : ‎ 89 pages