ISO 13485:2016 Practical Guide
This handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this publication. The handbook provides guidance on the requirements of ISO 13485:2016 and includes relevant information to help organizations understand and implement these requirements. Key topics: Publisher: Multiple. Distributed through American National Standards Institute (ANSI); Publication date: December 31, 2017; Language: English; Print length: 220 pages; Dimensions: 8.25 x 0.5 x 10.5 inches; ISBN-10: 9267107747; ISBN-13: 978-9267107745; Star rating: 4.6 out of 5; Review count: 3 global ratings.
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