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ISO 13485 - New Facility Question

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by S. Desai, Jan 27, 2016.

  1. S. Desai

    S. Desai New Member

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    We are medical device software company that manufactures stand alone software. Our headquarters is ISO 13485 certified and is audited annually by our notified body. We wanted to open another facility in the US where we would only be using that facility for Research and Development, not manufacturing. There would only be engineers that would be writing some code for new products.

    Should this new facility comply with ISO 13485 if we are not manufacturing there? Should our notified body be able to audit that facility? Can anyone point to the standard for any support? Thank you in advance for your help.
     
  2. JCIC49

    JCIC49 Member

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    The simple answer to your question is yes.

    The requirements are covered in ISO 13485 clause 7.3 Design and Development. This should already be part of the audit carried out at your current facility unless you have excluded this and are not doing any design and development work.

    Your Notified Body will need to be made aware of this facility so that they can include this in their audit.

    I would suggest talking to your notified body about this and ensuring that they are aware of what you are doing as the last thing NB's like are supprises.
     
  3. S. Desai

    S. Desai New Member

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    Great! Thank you for the information. There has been a lot of internal back and forth on this topic so it is nice to see a third party perspective.
     

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