Remanufacturing of Ultrasound Medical Devices

Abstract

Medical devices are subject to a number of post-sale aftermarket technical support activities, including servicing, upgrading, updating, refurbishing, and remanufacturing. These activities, when performed correctly and in conformance with applicable regulations and Standards, can ensure safe and effective performance over the lifecycle of the device. The regulated community of medical device manufacturers who must adopt good manufacturing practices also includes remanufacturers of those devices. Remanufacturer refers to “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.” 21 C.F.R. §820.3(w). If, after a postmarket technical support activity event, the device has not been properly rewired or has unvalidated parts installed, the risk that an individual interacting with the device receiving an electrical shock is significantly increased