01
Regulatory compliance
FDA UDI and EU MDR require permanent, unique identification on most medical devices.
JD Group / JD Systems / UDI solutions
Permanent traceability for medical devices
Unique Device Identification marking that survives sterilization, handling, and a device’s full lifecycle — engineered for FDA and EU MDR compliance.
Speak to a specialistMark quality inspector
What a compliant mark actually looks like
A UDI mark only counts if a scanner can read it — years later, after sterilization. Switch the marking method to see how grade parameters change under ISO/IEC 29158 direct part marking assessment.
Cell contrast96%
Cell modulation94%
Grid non-uniformity97%
Fixed pattern damage99%
Overall gradeA (4.0)
What is UDI?
A unique, traceable identity for every device
Unique Device Identification is a regulatory system that assigns a permanent, machine-readable identifier to medical devices and surgical instruments — linking each unit to its manufacturing data, lot, and lifecycle history.
Regulators including the FDA and the EU’s MDR now require UDI marking on most medical devices — making permanent, verifiable marking a mandatory part of manufacturing, not an afterthought.
DataMatrix on a surgical instrument
Why permanent laser marking
Why it matters for modern manufacturing
02
Full traceability
Every unit is linked to its lot, manufacturing date, and distribution history.
03
Patient safety
Faster recalls, adverse-event tracking, and reduced risk of counterfeit devices.
04
Survives sterilization
Laser marks stay legible through autoclaving, chemical cleaning, and years of use.
Our UDI process
From consultation to compliance
1
Compliance review
Assess FDA / EU MDR requirements for your device class.
2
Marking design
Define DataMatrix / GS1 content and placement.
3
System integration
Install and calibrate laser marking on your line.
4
Verification
Validate mark quality and readability to ISO standards.
5
Ongoing support
Maintenance and consulting as regulations evolve.
Standards & capabilities
Built for regulatory compliance
FDA UDIEU MDRGS1 standardsDataMatrix markingDirect part markingISO/IEC 29158 (DPM)Verification solutionsValidation supportProduction consulting
Get UDI-compliant with confidence
Our specialists provide consulting, verification, and validation support end to end.
Talk to a UDI specialist