I think another thing that is important to address in a supplier contract is to clearly define responsibilities. For example, if something goes wrong with the product, is it the company or supplier’s fault? According to the FDA, the device company is responsible for every component, even if those components are from other suppliers. However, I think this adds an extra importance to the previous discussion of the supplier notifying the device company about any changes. I think the contract should state that if the device company is not notified of changes and as a result, this causes something to go wrong with the product, the supplier should be at fault for not properly informing. If the supplier is making critical components, there should not be push back for this since they are taking on a lot of responsibility.