Foba has developed a laser marking process called HELP (Holistic Enhanced Laser Process), which enables medical device manufacturers to mark devices according to Unique Device Identifier (UDI) regulations set by the FDA.
HELP, developed by Foba for its laser marking machines with integrated vision system IMP (Intelligent Mark Positioning), allows medical device manufacturers to meet FDA identification requirements, while reducing production costs, minimising waste and improving product quality.
Apart from the marking of the medical product itself, HELP offers mark verification prior to marking and post-mark validation. During the post-mark verification process, the content of 1D and 2D codes, including data matrix codes, can be read directly, which is indispensable for compliance with the new UDI set by the FDA. The UDI regulation relates to marking and identifying medical devices within the healthcare supply chain.