News & Press

MDR start: May 26, 2021

Since the end of May 2021, the UDI (Unique Device Identification) enables the unique identification and secure traceability of medical devices as part of the European MDR (Medical Device Regulation) and improves patient safety.

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Scientifically determined laser parameters for UDI marking

In March 2019, FOBA provided the Innovation and Research Center (IFC) Tuttlingen at Furtwangen University (HFU) with a laser marking system. Since then, the system has proven itself in scientific research as well as for demonstration purposes in front of interested parties from the surrounding medical technology industry.

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FOBA laser marker handed over to university in Tuttlingen

El Centro de Innovación e Investigación (IFC) de Tuttlingen de la Universidad de Ciencias Aplicadas Hochschule Furtwangen (HFU) y FOBA Laser Marking + Engraving han puesto en marcha oficialmente su cooperación en materia de innovación para la tecnología médica. En una ceremonia celebrada el 20 de marzo en las nuevas salas del IFC se presentó un moderno sistema de marcado por láser.

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Laser marking on innovative material for medical devices

The Tuttlingen based Innovation and Research Center (IFC) of Furtwangen University (HFU) and FOBA Laser Marking + Engraving are starting a cooperation for developing innovations in the medical industry. Medical device manufacturers are invited to take part in the kick-off event on March 20, 2019 in Tuttlingen. The event is titled "Help, the UDI is here!" and deals with the technical requirements of laser marking on medical devices of various materials like metals and plastics.

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Better Patient Safety due to UDI-Marking on Medical Implants

Severe criticism against manufacturers of medical devices and related supervision processes occurred in November 2018, when European journalists questioned the reliability of implants and their possible effects on human health. The German inter-trade organization BVMed put this into perspective and additionally pleaded for an official nationwide implant database. FOBA encourages this approach and considers UDI-codes, firmly applied on medical implants, to be a key-factor for safe traceability of implants.

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Reduced Cost, Higher Speed and Improved Usability

With the launch of its latest laser marking software version, MarkUS 2.12, FOBA introduces not only a range of advancements in vision-based laser marking, but also a great potential for cost-savings in direct part marking. The update’s major enhancement is the patent-pending full-field imaging technology FOBA Mosaic which enhances automated mark alignment and saves expenses by making product fixtures obsolete.

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Precise Laser Mark Positioning even without Product Fixtures

At the IMTS in Chicago FOBA will showcase its innovative marking feature MOSAIC, a significant improvement in automated mark alignment, for the first time in the US. A reliable vision-based laser marking process is now even feasible when products are placed without any fixtures in the marking field.

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New Laser for Paint Removal – Highest Precision with 50 Percent Shorter Process Time

FOBA Laser Marking + Engraving presents a new generation of laser markers which meet the latest challenging precision and speed requirements for paint removal, such as day-night-design applications. The international market leader, who has decades of experience in the development of process-oriented laser marking systems, worked in close cooperation with worldwide customers on a laser solution which is custom-made for the most precise layer removal.

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Long term resistance of UDI laser marking proved for the first time by durability test on surgical instruments

In close cooperation with FOBA Laser Marking + Engraving, “add’n solutions GmbH & Co. KG” of Tuttlingen/Germany, a service provider for UDI laser marking on medical devices, conducted a long term study on reusable surgical instruments. The aim was to prove that laser marks remain clearly readable in spite of multiple reprocessing procedures. The UDI must resist increased wear throughout the whole product life cycle to ensure safe traceability, which is also officially required.

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FOBA launches feature-enhanced software update and autofocus function for more efficient laser marking

FOBA’s laser marking software MarkUS has been updated and equipped with a simplified runtime graphical user interface: The new “Advanced Operator PlugIn” (AOP) clearly visualizes the essential steps of the marking process and thus prevents operator errors. Also available now for easier application: A patent pending autofocus system that speeds up and streamlines the laser focusing process during job creation.

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FOBA presents Laser Marking Machines for UDI compliant marking of medical devices at the Medtec Europe

The UDI rule for medical devices is a big topic among manufacturers. The deadline for the third phase of the US-American Food and Drug Administration (FDA) initiated UDI system ends this year. It affects all producers of reusable class III products – such as neurological and cardiovascular catheters – and several class III devices that are single use implants and are sterilized (or cleaned and sterilized) before use – such as heart valves, pacemakers or knee prosthesis. Those devices have to be directly marked with UDI code from September on. FOBA shows economic and efficient laser solutions in Stuttgart for those requirements.

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Precise, flexible and easy to integrate: A new generation of Yb fiber lasers for marking plastics, metals and many other materials

With its Y-Series, FOBA is introducing the next generation of high-precision fiber lasers for direct part and product marking. With their newly developed scan head technology and the modular design, the laser marking systems in the Y-Series provide highest integration capability and application flexibility: They are easy to integrate into production lines and laser marking stations, and ensure tailored solutions for a wide variety of marking applications. A scan head built-in vision system for in-process imaging combines validation and verification prior to and directly after laser marking in a holistic marking process.

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Increased recalls in the automotive industry: How vision-based laser marking ensures uncompromising traceability

2014 was a record year of recalls in the automotive industry which cost the carmakers dear: almost 64 million vehicles have been recalled for safety problems solely in the USA, and more than 1.9 million vehicles in Germany. This trend is observable in many other countries as well, and did not stop in 2015. A current example: In August 2015, a luxury carmaker recalled almost 20,000 cars in China because of problems with the brake hoses. This is where innovative laser-based parts marking solutions come into play. They ensure more product safety and reliable traceability.

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Innovative laser technology overcomes challenges in marking of plastic

Plastic and plastic parts are used in nearly every industry. For traceability and quality assurance reasons or because of protection against plagiarism, plastic parts have to be readable and permanently marked. As the marking is usually a process at the end of the product line, it requires cost-effective and qualitative solutions. At Fakuma, FOBA – leading manufacturer of laser-based process solutions and parts marking – shows how vision-based laser technology supports not only the efficiency of product lines but also innovative design, security of products and traceability.

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Laser marking medical devices

Lasers are used in different ways for processing medical devices. Laser marking machines with integrated vision systems emerged as an effective means of identifying medical components, e.g. for marking UDI compliant codes.

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