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ISO 13485 - Medical devices

ISO 13485:2016 – Medical devices – A practical guide

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Kehtiv alates 22.09.2017
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22.09.2017
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Mapped to the structure of ISO 13485:2016, the new handbook offers step-by-step guidance for all organizations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical product’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing and post-market surveillance of medical devices. Aimed at all organizations, regardless of size and the nature of their business, it helps create a level playing field and facilitate the market access of their products globally. The handbook can be used as the go-to reference when questions arise about specific requirements, their interpretation, and implementation strategies. The handbook also serves as a practical guide for auditors, regulatory agencies and certification bodies, providing in-depth perspective on how requirements can be fulfilled to meet national regulations. It thus allows for a better understanding of the standard when preparing or conducting external and internal audits, as well as establishing local regulations and guidelines. Alongside its thorough description of ISO 13485, the new handbook also incorporates information from other sources of best practice most commonly used in the medical devices industry to meet the requirements of ISO 13485:2016.
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CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Uusim versioon Kehtiv alates 02.04.2018
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EVS-EN ISO 13485:2016

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded
Uusim versioon Kehtiv alates 02.03.2016
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EVS-EN ISO 14971:2012

Meditsiiniseadmed. Riskijuhtimise rakendamine meditsiiniseadmetele
Kehtetu alates 02.01.2020
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ISO 13485:2016

Medical devices -- Quality management systems -- Requirements for regulatory purposes
Uusim versioon Kehtiv alates 25.02.2016