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I realize that if SW is provided on a CD directly to Customers for installation on computer to support their medical device, the Sponsor must demonstrate compliance to the applicable parts of 21 CFR 820. The sponsor must have labeling on how to use the software, have CD labeling, tracking information, and inventory of CDs. If instead of relying on customers to install the SW on their computer the Sponsor provided this service to customers through their trained authorized personnel, will their be a reduction in the number requirements that need to be met or adhered to?
thanks.
thanks.