Hi guys,
I have a question.
We are certified according to EN ISO 13485, but we do not have a CE mark, we do not produce under our own trademark, but we are subcontractors (producing for the client, semifinished (unsterile) products).
Our cliet is asking for a Certificate of Conformity to be sent with every shipment and this document to be included in our Quality Assurance System.
So I was wondering if this is correct, if I can include it in the system and issue it even though we do not have Ce mark?
Thank you, wishing you all lovely day,
kapinka