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FDA & ISO 13485 Customer Supplied Material

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by ASFAR _to_ISOFDA, Jun 8, 2017.

  1. ASFAR _to_ISOFDA

    ASFAR _to_ISOFDA New Member

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    What is the medical Device industry standard practice for Customer supplied material?

    Does the customer get treated as a standard supplier or does customer take the risk upon them and we do minimal ID and Damage and cert?
     
  2. yodon

    yodon Active Member

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    May need some clarification.

    Are you a Contract Manufacturer receiving material from your customer (the "manufacturer of record") to be incorporated in a device? Or are you the manufacturer of record receiving material from your customer (the device end user) for some purpose?
     

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