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ISO 13485 documentation question

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Guest user Created:   Mar 02, 2021 Last commented:   Mar 03, 2021

ISO 13485 documentation question

 if we are only a distributor but may have to register products in the future would be these be the files that we would need

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 03, 2021

If you are a distributor of medical devices and may have to register products in the future, you have to have implemented ISO 13485:2016.

For more information about ISO 13485, please see following articles:

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