Precision, repeatability and compliance
Validated marking systems for medical devices
Designed for regulated environments. Proven in medical production. Built for long-term reliability.
Precision, repeatability and compliance
Designed for regulated environments. Proven in medical production. Built for long-term reliability.
Medical devices must remain identifiable, legible, and compliant throughout their entire lifecycle — from production and sterilization to use in clinical environments.
Yet many manufacturers face recurring challenges where printing becomes the weakest link in an otherwise controlled process.
“Printing failures in medical device manufacturing don’t stay small.
They turn into reauditing, high scrap rate, production delays, and lost approvals.”
Sales manager, Healthcare group division
Typical environments include:
(FDA-regulated manufacturing (21 CFR, cGMP); EU MDR / IVDR requirements;ISO 13485 quality systems; GAMP 5–aligned approaches for data-driven marking systems; USP Class VI material requirements (where applicable); REACH & RoHS compliance)
❌ Batch-to-batch variation in print quality
❌ Markings fail after sterilization
❌ High scrap and rework caused by marking defects
❌ Downtime due to print adjustments, changeovers, or failed inspections
❌ Low OEE driven by marking-related stops and manual checks
❌ Inconsistent printing on curved, irregular, or flexible surfaces
❌ Micro-printing lacks precision, contrast, or repeatability
❌ Audit findings related to labeling, traceability, or validation evidence
✅ Stable, recipe-based printing processes
✅ Medical-grade inks and validated print durability
✅ Integrated inspection and process stability
✅ Fast changeovers with stored recipes
✅ Automated, repeatable marking processes
✅ Pad printing optimized for complex geometries
✅ Ultra-high print quality for micro and fine-detail marking
✅ In-house validation aligned with industry requirements
Validation is performed by our specialists in-house, following relevant industry standards and best practices.
1
We use intelligent systems with automatic calibration, vision verification, and recipe management to ensure marking is highly repeatable — even across complex shapes and tiny geometries — without relying on operator guesswork.
2
Our approach embeds controls and validation criteria into the marking process so it consistently meets durability, sterilization, traceability, and regulatory requirements — reducing variability between batches.
3
By defining process parameters up front and capturing them in repeatable recipes, changeovers are faster, scrap is minimized, and production performance (OEE) improves, turning marking into a predictable part of your workflow.
Drug delivery devices
(auto-injectors, pens, syringes, wearable injectors)
Inhalers and respiratory devices
(MDIs, DPIs, dose counters, housings, cartridges)
Diagnostic devices and components
(cartridges, test cassettes, housings, connectors)
Surgical instruments and reusable devices
(handles, indicators, identification markings)
Implantable and implant-related components
(tools, accessories, trial components)
Disposable medical devices
(catheters, connectors, valves, housings)
Medical electronics and micro-components
(sensors, connectors, control units)
Medical devices are manufactured from a wide range of materials.
Pad printing and laser marking can be applied to:
✔ Polypropylene (PP)
✔ Polyethylene (PE)
✔ ABS
✔ Cyclic Olefin Copolymer (COC)
✔ Cyclic Olefin Polymer (COP)
✔ Polycarbonate (PC)
✔ PEEK
✔ Silicone
✔ Stainless steel
✔ Anodized aluminum…
Low surface energy plastics may require pre-treatment to ensure reliable ink adhesion.
Start with your challenge
Send us your part drawing & marking requirement — we’ll propose a validated printing concept
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