ISO-13485-HANDBOOK › Medical devices - A practical guide

ISO-13485-HANDBOOK - EDITION 1 - CURRENT


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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.
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Document Number

ISO 13485:2016 - Medical Devices - A Practical Guide

Revision Level

EDITION 1

Status

Current

Publication Date

Jan. 1, 2017

Committee Number

ISO/TC 210