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Is ISO 9001 mandatory for company distributing medical devices?
Is ISO 9001 mandatory for company distributing medical devices?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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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Jul 09, 2021
Jul 13, 2021
Jul 13, 2021