Risk Classification For Supplier - Clinical Research Organisation (CRO)

[Manny84]

I am in process of approving a Clinical Research Organisation (CRO) to support our clinical investigations. Are there guidelines for supplier risk classification that i can use to determine risk level of the CRO?

 

[Ronen E]

What field are you in?

 

[Manny84]

I am in medical device field

 

[Ronen E]

You should follow your own SOP dealing with supplier assessment, selection and qualification. If it's silent about the topic consult ISO 13485:2016.