In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments. Regardless of the application, lasers are the preferred choice for medical manufacturers who need precision and clarity in direct part marking.
TRUMPF has developed laser marking products medical manufacturers need to meet FDA requirements. Although the initial cost is higher than CO2 laser technology, TruMark YAG lasers are preferred for direct marking due to their low cost of operation. The exceptional beam quality provided by high quality YAG lasers is the basis for achieving marks for easy to read identification. These markings easily withstand the rigors of passivation—a necessity for customers manufacturing surgical instruments or similar devices. As more customers look to meet the UDI requirements, TRUMPF has experienced a clear increase in demand for TruMark lasers. Drawing on over 40 years of technical expertise, TRUMPF has designed a special package for the technology, giving medical customers a simple and more economical way to meet the FDA requirements.