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I have a unique situation regarding veterinary medical device and ISO 13485. Here is the run down...
My company (B) is ISO 13485 certified. we make both veterinary and clinical in vitro diagnostic devices (culture media and broths).
We just partnered with another company (F) that is going to manufacture a totally new product for in vitro diagnostics in animals for us. This product that they make will have our name and label on it. We will be distributing the product. "F" is not ISO 13485 certified. What would our CB want us to do in this situation? And, is it even applicable since it is a veterinary device?
I appreciate the feedback!
My company (B) is ISO 13485 certified. we make both veterinary and clinical in vitro diagnostic devices (culture media and broths).
We just partnered with another company (F) that is going to manufacture a totally new product for in vitro diagnostics in animals for us. This product that they make will have our name and label on it. We will be distributing the product. "F" is not ISO 13485 certified. What would our CB want us to do in this situation? And, is it even applicable since it is a veterinary device?
I appreciate the feedback!