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.

January 9, 2017

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, 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.

Please visit for more information www.fobalaser.com.

FOBA at MD&M West: booth #3274
February 7-9, 2017 | Anaheim Convention Center | Anaheim, CA

For additional information and to forward reader responses please contact:

Armin Fera | Campaign Manager
ALLTEC GmbH | An der Trave 27 – 31 | 23923 Selmsdorf/ Deutschland
Tel.: +49-(0)38823 55-544 | Fax: +49-(0)38823 55-222
[email protected] | www.foba.de | www.fobalaser.com

About FOBA
FOBA Laser Marking + Engraving is among the leaders in manu¬factur¬ing and supplying precision laser systems for marking and engraving. FOBA marking lasers mark a variety of materials and parts not least in the key markets of Automotive and Medical but also in Electronics, Plastics, Safety and ID. FOBA laser workstations for marking and engraving are especially applied in the fields of Automotive part production and Medical device marking as well as in Tool, Metal and Mold Making, Plastics processing and Jewelry. Worldwide sales and service branches service the most important markets.
In September 2009, FOBA has become part of ALLTEC GmbH. Since then, FOBA is part of ALLTEC as a sales channel for laser part marking and engraving.