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Medical Device storage and shipment



  • Anon
    22/01/2021 12:32
    Dear, Our sponsor is asking us (CRO) to assist with the storage and shipment of investigational medical devices to sites. I am wondering if there are any specific regulations/requirements we need to take into account besides general accountability procedures? Kind regards
  • Anon
    22/01/2021 18:08
    Hopefully you have sent this question to RQA Devices Commiitte? Best to look at medical device regulations and the ISO guideline on GCP for medical devices. Product accountability is always needed for an experimental treatment.
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