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Is ISO 9001 mandatory for company distributing medical devices?

ISO 13485 & EU MDR
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Guest user Created:   Jul 09, 2021 Last commented:   Jul 13, 2021

Is ISO 9001 mandatory for company distributing medical devices?

ISO 13485 & EU MDR
Is ISO 9001 mandatory for company distributing medical devices?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Jul 13, 2021

No, ISO 9001 is not mandatory for the companies distributing medical devices. However, in the ISO 13485: 2016 standard in section 0.1 Introduction - General it is stated that the ISO 13485:2016 standard can be used by an organization involved in one or more stages of the lifecycle of a medical device including design and development, production, storage and distribution and so on.

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