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.

ISO 13485:2016 - Medical devices - A practical guide

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  • In bundle

    Bundle
    Medical devices - the basics

    This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

    • ISO 13485:2016
    • ISO 13485:2016 A practical guide
    • ISO 14971:2019
    • ISO/TR 24971:2020
    English | PDF
    CHF 658

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