ISO - ISO 13485:2016 - Medical devices

Página de portada: ISO 13485:2016 - Medical devices - A practical guide

Año de publicación: 2017 | Edición: 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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Normas relacionadas

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13485 - Quality management for medical devices

A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.

Más información

In bundle
ISO 13485:2016 + ISO 13485:2016 - Medical devices - A practical guide + ISO 14971:2019 + ISO/TR 24971:2019

English

ISO 13485:2016 ISO 13485:2016 59752 173 ISO 13485:2016 - Medical devices - A practical guide ISO 13485:2016 - Medical devices - A practical guide pub100484 96 ISO 14971:2019 ISO 14971:2019 72704 173 ISO/TR 24971:2020 ISO/TR 24971:2020 72704 216
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