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ISO13485: Marketing materials and design files

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Ana Silva, Aug 24, 2021.

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  1. Ana Silva

    Ana Silva New Member

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    I work at a startup as a QA/RA and am working on document control. I am trying to figure out which marketing and design documents needed to be controlled and reviewed according to ISO13485. To which type, what information needs to be controlled.
    Can anyone help me? Thank you
     
    Ana Silva, Aug 24, 2021
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  2. yodon

    yodon Well-Known Member

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    Generally, anything with claims should be controlled (including your website / pages!). I'd suggest that you (as regulatory) review everything, at least, to determine if it qualifies for control.
     
    yodon, Aug 24, 2021
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    Andy Nichols likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well said, Yodon. I had the same thoughts.
     
    Andy Nichols, Aug 24, 2021
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  4. Ana Silva

    Ana Silva New Member

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    Thank you for your suggestion
     
    Ana Silva, Aug 24, 2021
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