HELP for Compliantly Marking Medical Devices

Laser Marking Machine FOBA M2000 with new fiber laser Y.0200 (Source: Foba)

Laser Marking Machine FOBA M2000 with new fiber laser Y.0200 (Source: Foba)

Regarding identification and marking tasks, manufacturers of medical devices face a challenging situation: regulations are getting stricter, contents more complex. Also the number of products which have to be marked increases continuously – this intensifies the need for manufacturers to take the efficiency of their production lines into account. The key to meeting the FDA identification requirements while reducing production costs, minimizing waste and improving product quality is the laser marking process Holistic Enhanced Laser Process HELP, developed by Foba for its laser marking machines with integrated vision system IMP, Intelligent Mark Positioning.

Apart from the marking of the medical product itself, HELP offers mark verification prior to marking and post-mark validation right after marking. Particularly important for medical device manufacturers: During the unique post-mark verification process, the content of 1D and 2D codes – e.g. Datamatrix [ECC200] GS1 compliant and graded – can be directly read which is indispensable for compliance with the new Unique Device Identifier set by the FDA. Foba laser marking systems are capable of marking DataMatrix codes to support the new FDA’s Unique Device Identifier UDI used to mark and identify medical devices within the healthcare supply chain.

Medical clamp with annealed 2D code. (Source: Foba)

Medical clamp with annealed 2D code. (Source: Foba)

Besides these medical identification solutions Foba will showcase the new generation of Yb fiber lasers at MD&M West. With their newly developed scan head technology and the modular design, the fiber laser marking systems in the Y-Series provide highest integration capability and application flexibility. Attendees can experience Foba lasers and part marking during live demos. (Source: Foba)

Links: FOBA, ALLTEC GmbH, Selmsdorf, GermanyMedical Design & Manufacturing MD&M West, February 09-11, 2016, Anaheim, CA, USA

 

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