Precision, repeatability and compliance
Validated marking solutions for medical devices
Designed for regulated environments. Proven in medical production. Built for long-term reliability.
The Reality of Printing in Medical Device Manufacturing
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.”
Harko van Egmond
Sales manager, Healthcare group division
Typical environments include:
- Strict regulatory oversight
(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)
- Sterilization and chemical exposure
- Small, complex, or flexible components
- High documentation and validation requirements
The Problems Medical Device Manufacturers Face
❌ 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
Printing International Solutions
✅ 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.
We engineer the process, not just the machine
1
Automated, repeatable marking with built-in quality control
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
Process robustness for regulated manufacturing environments
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
Minimal setup, reduced waste, and predictable outcomes
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.
Applications in medical Device
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)
Start with your challenge
Start with your medical device marking challenge!
Send us your part drawing & marking requirement — we’ll propose a validated printing concept
Pad printing and laser marking Machines for medical productions
- Automatic Servo/Pneumatic
- 1-6 ink cup
- Visual inspection, rejection system
- up to 18 000 pcs/h
- Automatic Servo/Pneumatic
- 1-4 ink cup
- Visual inspection, rejection system
- up to 20 000 pcs/h
- Automatic/Pneumatic
- 360° printing
- 1-2 ink cup
- for multiple product sizes
- visual inspection optional
- up to 20 000 pcs/h
- Automatic/Any laser technology
- Servo controled
- Flat & rotary marking applications
- up to 20 000 pcs/h
- Combined pad printing and laser marking
- Variable data and graphics
- Flat and rotary
- up to 20 000 pcs/h
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