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ISO 13485:2016 - Medical Devices - A Practical Guide

Medical devices - A 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.


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International Organization for Standardization [iso]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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