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DMR Maintenance and Servicing Procedures Clarification 820.181

Discussion in 'Medical Devices (21 CFR Part 820)' started by John Thacher, Dec 17, 2020.

  1. John Thacher

    John Thacher New Member

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    Hi guys, a question recently came up relating to DMRs. Does anyone have any clarification on what is specifically meant by "(E) Installation, maintenance, and servicing procedures and methods". Does this refer to installation maintenance and servicing of the medical device or does it refer to installation and maintenance of equipment used in the manufacture of the device?
     
  2. yodon

    yodon Well-Known Member

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    My understanding is that this is the equipment necessary to manufacture the product. Installation of the device is covered in 820.271 and service of the product is covered in 820.200.
     

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