Risk Classification For Supplier - Clinical Research Organisation (CRO)

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Manny84

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#1
#1
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?
 
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Ronen E

Ronen E

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#4
#4
You should follow your own SOP dealing with supplier assessment, selection and qualification. If it's silent about the topic consult ISO 13485:2016.
 
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