Laser Marker Can Help Device-Makers Meet FDA Regulations

At Plastec West / MD&M West, February 7-9, in Anaheim, California, Alltec GmbH’s FOBA Laser Marking + Engraving brand will showcase its M2000 laser marking workstation, which features an integrated vision alignment and verification system that automatically detects devices and their positioning, and aligns marks relative to a part’s position.

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At Plastec West / MD&M West, February 7-9, in Anaheim, California, Alltec GmbH’s FOBA Laser Marking + Engraving brand will showcase its M2000 laser marking workstation, which features an integrated vision alignment and verification system that automatically detects devices and their positioning, and aligns marks relative to a part’s position. The workstation offers the flexibility of marking medical devices, including with machine- and human-readable codes that meet the U.S. Food and Drug Administration’s Unique Device Identification (UDI) requirements.

FOBA’s vision solutions are part of its Holistic and Enhanced Laser Process (HELP) closed-loop laser marking process, which covers pre- and post-mark verification in three states. The first stage covers part validation, pre-mark verification and mark alignment; the second stage is the laser marking itself; and the third stage covers mark and optical character verification, and 2D code validation such as those required for UDI.