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Documentation to file decision

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  • Shea
    04/09/2015 14:51
    Hi, Can a Class I device undergoing design and material change will need a documentation to file? The device is an accessory to a class II device accessory and change is being done in response to customer complaint. Thank you.
  • Medical Devices Committee
    05/10/2015 11:30
    Material changes to the device will need to be documented with full design review including the purpose and effect of the change, as well as an update to device risk assessments.
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