ISO 13485 & EU MDR / 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.
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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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