Selmsdorf, Germany – Over the past two months, the FDA has begun enforcing its UDI ruling. Every medical device manufacturer who is not yet marking his products UDI-compliant, has to act now, if he doesn’t want to be put out of business for misbranded products. FOBA can show you how to conform to all standards and regulations and also demonstrates how machine-integrated vision systems combine high accuracy with cost efficiency. The company is an international market and technology leader of systems and integrated solutions for laser marking and engraving. One of the latest innovations is the new patented auto focus that will be presented for the first time to a broad audience at its booth.
Manufacturers of medical devices face multiple challenges. On the one hand, there is the Unique Device Identification (UDI) regulation mandated by the FDA, in place. The FDA requests that a machine and human readable code be applied to more and more medical device products. The FDA has begun enforcing these rules as of November 2016. On the other hand, there is an increasing variety of medical devices that need to be marked, typically combined with budgetary pressure in many companies. FOBA, aware of those challenges, therefore developed its flexible, cost-efficient and reliable laser labelling systems.
At the MD&M West 2017, booth #3274, FOBA showcases its high-precision and cost-effective laser marking workstation, the FOBA M2000, with an integrated vision alignment and verification system. This integrated high-speed camera system automatically detects devices and their positioning, and aligns the mark relative to the part’s position – a significant benefit for clients with a large product portfolio. With FOBA’s vision solutions, manufacturers achieve an almost zero-defect marking quality which could grant them a decisive advantage in a market as competitive as the medical sector.
FOBA’s vision solutions are part of the closed-loop laser marking process HELP (Holistic and Enhanced Laser Process) which covers pre- and post-mark verification. HELP is a process of three stages. The first stage covers part validation, pre-mark verification and mark alignment – followed by the laser marking itself. The third stage covers mark and optical character verification (OCV) and 2D code validation such as those required for UDI.
Source: FOBA