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dabelincoln
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I was hoping you guys can help me with something. We outsource our overflow designs to areas around the world. This usually works well for us but we’re having some issues when we outsource our implant designs that use DMEs with FDA signatures.
Our outsource partners cannot use our DMEs because they are geo-restricted to the USA to meet FDA compliance. They get an error: “This parts signed DESS implants for US(C),and the adapt items at the station did not open or key files into this computer did not update, please contact your supplier to get information about permission to use the document with this signature.”
So I contacted the implant provider and asked if they had any DMEs that are not geo-restricted and they gave me the ones that they use for the rest of the world. Our outsource partners were able to import the region free DME into their system and work on our cases. However, when we import their designs back into our system we’re unable to make any edits. When we go into the designer it tells us that we need to use an FDA approved library for our region and then it shuts it down.
Is there anything we can do about this? I can understand the US not being able to use region free DMEs in order to meet FDA compliance, but why are other areas of the world restricted from using the FDA compliant DMEs? What are other design centers doing when they're faced with this issue?
Let me know, thanks!
Our outsource partners cannot use our DMEs because they are geo-restricted to the USA to meet FDA compliance. They get an error: “This parts signed DESS implants for US(C),and the adapt items at the station did not open or key files into this computer did not update, please contact your supplier to get information about permission to use the document with this signature.”
So I contacted the implant provider and asked if they had any DMEs that are not geo-restricted and they gave me the ones that they use for the rest of the world. Our outsource partners were able to import the region free DME into their system and work on our cases. However, when we import their designs back into our system we’re unable to make any edits. When we go into the designer it tells us that we need to use an FDA approved library for our region and then it shuts it down.
Is there anything we can do about this? I can understand the US not being able to use region free DMEs in order to meet FDA compliance, but why are other areas of the world restricted from using the FDA compliant DMEs? What are other design centers doing when they're faced with this issue?
Let me know, thanks!
