Thermage FLX Handpiece OUS Service Procedure

Abstract

High international shipping cost and repair turnaround times negatively affect Solta Medical’s revenues. The cause of these costs and turnaround times stem from the inability to calibrate repaired handpieces internationally since they require intellectual property at risk of counterfeit. An alternate test procedure was developed that allowed global service affiliates to perform repairs of the handpiece and test to see if they remained within calibration before putting them back into service. The test procedure was validated and proved feasible. Key Terms ⎯ Field tests; international shipping; international repairs; repair lead-time; process validation; control limits.