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Is ISO 13485 applicable to a non-profit organization?

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Guest user Created:   Apr 16, 2019 Last commented:   Apr 16, 2019

Is ISO 13485 applicable to a non-profit organization?

We are a non-profit organization that ships supplies and equipment to international partners throughout the world. We have recently been asked to provide documentation to prove our used/donated medical equipment meets ISO 13485 certification requirements. How can this be accomplished?
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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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Verlene Law Apr 16, 2019

Answer:

In this case, you have to contact the donors ( the companies that donated the medical equipment) to get the ISO 13485 certification from them.

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Apr 16, 2019

Apr 16, 2019

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