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We sell the bulk of our medical devices through distribution. As such, we have never had a program where we would sell refurbished units direct to customers. However, we routinely get customer returns that have been opened and used a few times, or opened and never used. These come into our repairs department and often times are made into loaners for shipment to customer while their unit is being repaired.
We now have more units than we need for loaners and someone got the idea that we could refurbish them and donate them.
We are currently the manufacturer, and aside from some aesthetic issues, the units would be refurbished to the same state as the unit that are manufactured (minus the consumables that are shipped with the new units). I believe our current Quality System should suffice and that since we are already registered as the manufacturer of the device, we should be able to refurbish it as well.
It just seems like I'm missing something. We don't fit the technical definition of a remanufacturer or reseller as we made the product originally. Any thoughs?
We now have more units than we need for loaners and someone got the idea that we could refurbish them and donate them.
We are currently the manufacturer, and aside from some aesthetic issues, the units would be refurbished to the same state as the unit that are manufactured (minus the consumables that are shipped with the new units). I believe our current Quality System should suffice and that since we are already registered as the manufacturer of the device, we should be able to refurbish it as well.
It just seems like I'm missing something. We don't fit the technical definition of a remanufacturer or reseller as we made the product originally. Any thoughs?