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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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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:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
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