T
TamTom
Hello,
we are in the process to close one of our plants, in Europe, and in the future the basic for our dental alloys bits, will come from US, we in Germany will to the further processing and selling in Europe, for this and one other reason we are planning to get the ISO 13485 certificate in Germany. The US plant will also process and sell the alloys on the US market, know we have the discussion who will be responsible for the design history files and if US plant should get a ISo 13485 certificate.
Now my question, what is mandatory for the US plant to sell the alloys in US, and does anybody has an idea if any "approval" in US is accepted in Europe?
Does somebody know if the FDA Documents for Devices are accepted in europe?
Regards,
Tamara
we are in the process to close one of our plants, in Europe, and in the future the basic for our dental alloys bits, will come from US, we in Germany will to the further processing and selling in Europe, for this and one other reason we are planning to get the ISO 13485 certificate in Germany. The US plant will also process and sell the alloys on the US market, know we have the discussion who will be responsible for the design history files and if US plant should get a ISo 13485 certificate.
Now my question, what is mandatory for the US plant to sell the alloys in US, and does anybody has an idea if any "approval" in US is accepted in Europe?
Does somebody know if the FDA Documents for Devices are accepted in europe?
Regards,
Tamara
Last edited by a moderator: