ISO 13485:2016 - Medical devices - A practical guide

Cover page: ISO 13485:2016 - Medical devices - A practical guide

Year of publication:    |   Edition: 1

ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The 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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  • CHF88

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The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose. 

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