ϲʿ 13485:2016 - Medical devices - A practical guide
Год публикации: 2017 | Версия: 1
ϲʿ 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ϲʿ/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ϲʿ 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.
ϲʿ 13485:2016 - Medical devices - A practical guide
Интернет-магазин ИСО
- Medical devices — Quality management systems — Requirements for regulatory purposes
- A free brochure with tips for getting started with ϲʿ 13485, requirements for quality management systems related to medical devices.
In bundle
ϲʿ 13485:2016 + ϲʿ 13485:2016 - Medical devices - A practical guide + ϲʿ 14971:2019 + ϲʿ/TR 24971:2019 ϲʿ 13485:2016 ϲʿ 13485:2016 59752 173 ϲʿ 13485:2016 - Medical devices - A practical guide ϲʿ 13485:2016 - Medical devices - A practical guide pub100484 96 ϲʿ 14971:2019 ϲʿ 14971:2019 72704 173 ϲʿ/TR 24971:2020 ϲʿ/TR 24971:2020 72704 216BundleMedical devices - the basics
This bundle combines essential ϲʿ standards to provide a robust framework for quality management and risk management in the medical device industry.
- ϲʿ 13485:2016
- ϲʿ 13485:2016 A practical guide
- ϲʿ 14971:2019
- ϲʿ/TR 24971:2020
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