Guide to German Medtech Companies 2021

Page 68

Name · FOBA Laser Marking + Engraving (Alltec GmbH)

Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Social Media Number of Employees Founded (year) Areas of Activity

· · · ·

An der Trave 27–31 23923 Selmsdorf Mecklenburg-West Pomerania Christian Söhner (Global Vertical Manager Medical) +49-38823-55-556 +49-38823-55-222 info@fobalaser.com www.fobalaser.com

· · · · · FL I Q  · 250 (worldwide) · 1969 (FOBA), 1985 (Alltec GmbH) · l Development and manufacturing of innovative laser marking and engraving solutions l Laser marking workstations and laser marking systems for OEM and integrators l Vision-inspection systems for part validation, automated mark alignment, pre- and post-mark code validation l Specialist for customised medical device UDI-marking solutions

External · l Medical Mountains Collaborations l Technology Mountains l GS1 Germany Solution Partner l HIBC Approved Solution Provider |V DMA Working Group Medical Technology | T 4M Messebeirat (trade show organization council)

Member of

Reliable laser direct part marking for product safety and traceability FOBA offers laser marking workstations or systems for the integration into production lines, as well as semi or fully automated workflows. Our marking solutions are specifically developed to fulfil the requirements of UDI direct part marking and help to achieve a higher throughput. FOBA’s innovative fibre laser, UV-, or CO2-laser marking systems are available with sophisticated vision inspection and software features to enable an error-free, automated, and safe laser marking process. Besides UDI there are various marking applications such as banding marks on hypodermic needles, micro codes on tiny pedicle screws, symbols on sensitive plastic material, 2D-codes on hospital equipment, or marks on metals that undergo multiple sterilisation processes. For each material and its individual functionality the appropriate marking parameters must be determined. FOBA understands laser marking as a comprehensive process. This means not only the three-step marking process itself, with pre-mark inspection, automated mark alignment, and post-mark validation. It already starts beforehand with application and documentation consulting and additionally includes full-service maintenance programmes such as technical support and training or spare parts and remote service.

UDI – increasing legal and formal requirements UDI (Unique Device Identification) codes must be machine/human readable in order to be obtained directly from the product and transferred further. Also according to legal requirements codes must be indelible and readable throughout the entire product life cycle. Laser marking, if applied accordingly, can guarantee sustainable marks on nearly all kinds of material. To be compliant with legal UDI guidelines, manufacturers also need to perform extensive documentation and validation of their products, equipment, and processes. To facilitate these qualification efforts FOBA provides IQ-OQ-PQ-MQ support.


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