ISO 13485 : a complete guide to quality management in the medical device industry The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step by step comparison between the ISO 13485 and ISO 9001 enabling a sound understanding of these new procedures Provided by publisher