Management is considering outsourcing manufacturing of a portable MRI machine to a vendor in Mexico. This product has only been on the market for two years. In that time, it has been a commercial success in North America and Asia. The company has a patent on this product and is currently the only company selling a portable MRI machine. The U.S. plant where the product is currently being made is not being closed. It will continue to be used to manufacture other products. The Mexican company being considered does manufacturing for other large U.S. medical device companies such as Medtronic and Boston Scientific.

• What are the most significant risks?
• What key controls need to be in place?
• What role can internal auditing play in assisting management both prior to signing the outsourcing contract and after the process has been outsourced?