5. UDI Compliance Checklist for Laser Marking

Use this checklist to ensure your laser marking process meets FDA UDI requirements:

Pre-Production

• [ ] UDI assigned by accredited issuing agency (GS1, HIBCC, ICCBBA)
• [ ] DI and PI components correctly defined for each device
• [ ] DataMatrix encoding follows the issuing agency’s format rules
• [ ] Code size and cell dimensions appropriate for device size
• [ ] Quiet zone meets ISO/IEC 16022 requirements

Laser Marking Process

• [ ] Mark type selected based on material and sterilization method (annealing for SS instruments)
• [ ] Laser parameters validated for each material-device combination
• [ ] Focus calibration verified before each production run
• [ ] Surface cleanliness confirmed (no oils, fingerprints, residue)
• [ ] First-article inspection performed and documented

Post-Marking Verification

• [ ] Machine-readable verification: DataMatrix grade ≥ C per ISO/IEC 15415
• [ ] Human-readable text legibility confirmed under standard clinical lighting
• [ ] Sterilization challenge: marks tested through actual reprocessing cycles
• [ ] Passivation challenge (for stainless steel): marks tested post-passivation
• [ ] Accelerated aging study completed for long-term mark durability

Documentation

• [ ] Process validation protocol and report completed
• [ ] Parameter records maintained (power, speed, frequency, focus)
• [ ] Material lot traceability documented
• [ ] Operator training records current
• [ ] Change control process established for parameter modifications