ISO 13485

id: iso-13485-166-829136
title: ISO 13485
text: ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488. The current ISO 13485 edi
brand slug: wiki
category slug: encyclopedia
description: ISO standard
original url: https://en.wikipedia.org/wiki/ISO_13485
date created: 2006-08-12T12:45:14Z
date modified: 2024-08-29T19:20:18Z
main entity: {"identifier":"Q1654689","url":"https://www.wikidata.org/entity/Q1654689"}
image:
fields total: 13
integrity: 15

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