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  • 1.  ISO 13485 or ISO 9001?

    This message was posted by a user wishing to remain anonymous
    Posted 03-Oct-2021 22:25
    This message was posted by a user wishing to remain anonymous

    Good morning or good evening everyone, 

    I would like to receive more insights on the following topic. Does a supplier of an accessory to a medical device (a bag) need to be ISO 13485 certified? Or is it sufficient to have an ISO 9001 certification? 

    Thank you very much for your help, 

    Kind regards


  • 2.  RE: ISO 13485 or ISO 9001?

    Posted 04-Oct-2021 04:05
    Dear Anon, please check this thread: link.

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


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