hi all,
we are new startup company for scar healing products (silicone gel padding), we checked it's belong to Class 1 MDR, we are very confuse what document do we need to prepare.
is that we can self-declaration for ISO13485, we own the IP for our product , but manufacturer is China factory. so do we also need to have QMS?
we are new startup company for scar healing products (silicone gel padding), we checked it's belong to Class 1 MDR, we are very confuse what document do we need to prepare.
is that we can self-declaration for ISO13485, we own the IP for our product , but manufacturer is China factory. so do we also need to have QMS?