Edited by Jeff Peterson, editor-in-chief, Plastics Decorating

In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards – from patient protection to regulatory compliance. Since direct part marking plays a key role in ensuring traceability and UDI conformity, it is essential that manufacturers of laser marking systems understand the complexities of industry-specific challenges, standards and workflows. Their expertise significantly contributes to the safety of medical devices, making them trusted partners for reliable and compliant marking solutions. When cutting-edge technology meets application know-how, laser marking becomes a true game changer – enhancing both safety and efficiency in production.

But what exactly defines “safe marking?” How can maximum safety be built into the laser marking process from the very beginning? What needs to be considered when marking medical devices? And how can reliable, compliant markings be achieved?

For applications that demand maximum marking quality, legibility and material integrity, Black Marking is the method of choice. This advanced technique uses ultra-short laser pulses to generate nanostructures on the material surface, resulting in a deep black, high-contrast mark with minimal thermal impact. Ultra-short pulse lasers are ideally suited for this process, offering precise parameter control and minimal thermal impact. Due to the highly focused and brief energy input, the resulting deep black marks form without significant heat exposure, preserving the material. The result – a marking that is durable, reliably legible from any angle, corrosion-free, biocompatible, biostable and UDI-compliant.

Advanced laser technology provides all the prerequisites for safe and compliant medical device marking. With exceptional precision, maximum material integrity and optimal legibility, it makes a decisive contribution to product safety and regulatory compliance.

LASTING SAFETY: DIRECT MARKING OF SENSITIVE MEDICAL DEVICES
Thanks to continuous innovation, laser marking increasingly is being used for materials and products that previously required alternative methods – including sensitive plastics and critical devices such as pacemakers and active implants. Traditionally, ink-based methods were used for these applications. However, in medical environments, inks and dyes are becoming less accepted due to issues related to biocompatibility and long-term readability. In addition, ink-based processes can result in higher scrap rates due to smudging or fading, and can require extensive quality control as well as drying times.

In contrast, laser marking is a highly efficient, contact-free process. It enables durable, abrasion-resistant and legible markings even on heat-sensitive materials. Alongside ultra-short pulse lasers, advanced UV lasers are ideal for marking delicate medical plastics. Because the marking is created through a photochemical effect and virtually involves no thermal stress, it is often referred to as “cold marking”. The result is a smooth, hygienic surface with a pin-sharp, abrasion-resistant mark. “The latest innovations in UV laser technology allow us to mark materials that were previously considered unmarkable,” said Philipp Febel, director of Product Management, Marketing & R&D at FOBA. “This is especially valuable for medical device manufacturers who rely on direct laser marking to meet strict regulatory requirements.”

FROM INSTALLATION TO QUALITY INSPECTION: PROCESS RELIABILITY BY DESIGN
But even the best marking alone is not enough to ensure maximum safety in medical technology. The marking process itself and its qualifications play an equally vital role in quality control. When laser manufacturers support qualification efforts, medical device companies significantly benefit. Understanding the optimal setup and adjustment of all parameters helps streamline the entire validation process. “Supporting IQ/OQ/PQ/MQ processes is a core part of our service offering,” explained Febel. “As laser experts, we contribute our knowledge directly to our customers’ workflows. This creates synergies that enable smooth, timely installation and qualification – the foundation for efficient, waste-free and stable production.”

Documented quality and stable processes that ensure repeatable marking results are essential for validation, product safetyw and UDI compliance. FOBA’s laser-integrated IMP (Intelligent Mark Positioning) vision system detects the part’s position and geometry before marking and automatically aligns the laser accordingly – ensuring precise placement regardless of how the part is positioned in the marking field. This especially is important in the context of miniaturization in medical technology. Whether on dental implants, minimally invasive instruments or catheters – automatic alignment and perfectly tuned parameters ensure reliable micro-markings where space is limited and precision is essential.

After marking, the result is verified inline – directly within the laser system – for both content and code quality. The results are automatically documented. This streamlined workflow reduces manual inspection, minimizes waste and enables seamless documentation of marking quality. HELP (Higher Efficiency Laser Process) delivers measurable value in medical device marking: more safety, more efficiency, less risk.

SMART, SCALABLE, SAFE: LASER MARKING IN MEDICAL TECHNOLOGY
Laser marking is more than just a marking method – it is the foundation of compliance, quality and traceability in medical technology. Comprehensive consultation, application testing and precise parameter adjustment are essential for meeting complex requirements. When expert knowledge, validated processes, vision-based precision and documented quality come together, laser technology makes a decisive contribution to both product and patient safety. Beyond that, this efficient marking method meets all the demands of modern production environments – with extremely compact marking systems, intelligent interfaces and digital, automated process solutions, the future already is built in.

Since 2023, ALLTEC/FOBA – headquartered in Lübeck near Hamburg, Germany – is part of the US-based Veralto Corporation. ALLTEC (Angewandte Laserlicht Technologie GmbH) with its FOBA Laser Marking + Engraving brand, is a leader in manufacturing and supplying innovative solutions for laser marking. FOBA`s marking lasers, laser marking workstations and vision-assisted laser marking workflows, mark a variety of materials and parts, including the key markets of automotive and medical, electronics, plastics and tool, metal and mold making. For more information, visit www.fobalaser.com.