FOBA offers more-efficient laser marking solution for FDA compliance

Jan. 12, 2017
A laser marking workstation is available for medical device makers to ensure that their products are UDI-compliant.

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 medical device products—rules that began to be enforced by the FDA in November 2016. Therefore, every medical device manufacturer that is not yet marking products with UDI-compliant codes has to act now if they do not want to be penalized for misbranded products. 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.

Aware of these challenges for medical device makers, FOBA (Wood Dale, IL) has developed flexible, cost-efficient, and reliable laser labeling systems. For example, the company's FOBA M2000 laser marking workstation with an integrated vision alignment and verification system automatically detects devices and their positioning, and aligns the mark relative to the parts' position—a significant benefit for clients with a large product portfolio. This allows manufacturers to 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 Holistic and Enhanced Laser Process (HELP) laser marking process, which covers pre- and post-mark verification. HELP's 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.

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