Marked for Life: Inside the World of Safe Medical Device Laser Marking
Laser marking plays a key role in traceability, UDI compliance, and product safety in the medical device industry. But what exactly makes a marking truly “safe,” and which factors need to be considered? This article outlines the essential requirements for safe medical device marking – from corrosion resistance and material integrity to validated processes. Practical examples and a case study illustrate how these requirements can be successfully implemented.
Laser marking is a critical element for traceability, UDI compliance, and product safety in the medical device industry. Key factors that define the safety of a marking include corrosion resistance, material integrity, and the validation of the entire marking process.
Especially for reusable devices made of stainless steel or titanium, the marking must remain durable and legible even after numerous cleaning and sterilization cycles. To meet the highest standards in legibility and surface protection, technologies such as Black Marking with ultrashort pulse lasers or marking with UV lasers for heat-sensitive plastics are used. These methods enable high-contrast, biocompatible, and abrasion-resistant markings—without thermal stress on the material.
In addition to the technology itself, process reliability is essential. Vision-based marking processes like HELP (Holistic Enhanced Laser Process) ensure precise positioning, automated quality control, complete documentation, and reproducible results – key criteria for product safety and for meeting regulatory requirements.
Combining expert knowledge, validated processes, vision-based precision, and documented quality, laser technology makes a decisive contribution to both product and patient safety.
The full article is available for download:
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Technical article_Safe laser marking of medical devices
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206 KB
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206 KB | docx |
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Technical article_Safe laser marking of medical devices
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525 KB
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525 KB | |
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FOBA-Photos-Medical-Device-Marking.zip
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312 KB
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312 KB | zip |