Receiving parts from supplier - medical device

[sophgira]

Hello everyone,

I am new at this quite small and new company and our main engineer recently ordered some parts from China as they are much more cheaper than our previous supplier in Europe, and also faster. We don't have many procedures in place yet for parts from suppliers, as we don't produce our medical device in big quantities (YET).

We are still in the process of getting MDR approval so we have a bit of time to test different suppliers. When we received those parts I realised that we don't have any procedures, forms, etc in place to inspect these parts or to compare them to previous ones. So my questions would be, what do you suggest we use? First, we didn't ask for a CoC from the supplier, should we do this? Second, should we write a report on the evaluation of these and why we are going with this supplier? These are electrodes, and other stainless steel parts.

Thanks for all the help!!

 

[QuinnM]

Hi Sophgira,
At a high level - The first step would be to qualify the supplier and place them on an approve supplier list. Once this is done, then your company may accept product from the supplier. Next is to have a specification for the product. Last, is the incoming inspection to ensure the product meets the specification.