ISO 13485 - Practical Guide

A practical guide to ISO 13485:2016 - Medical devices

Standard Details

This 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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Status : ACTIVE

Standard Type: Main

Document No: ISO 13485 - Practical Guide

Document Year: 2017

Edition: 1

Section Volume:
ISO/TC 210. Quality management and corresponding general aspects for medical devices

ICS:
03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, hea

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ISO 13485 - Practical Guide

ISO 13485 - Practical Guide

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