6. UDI Compliance Workflow: Ensuring Your Mark Passes the Test
Simply buying a laser machine isn’t enough. To be FDA compliant, your marking process must be validated. At HeatSign, we recommend the following 4-step workflow for surgical steel manufacturers:
Step 1: Pre-Marking Passivation (Optional but Recommended)
Clean the instrument to remove all oils and contaminants from the machining process.
Step 2: Laser Annealing with MOPA
Using a HeatSign HS-FL-MOPA system, mark the DataMatrix code (UDI) and human-readable text. The parameters must be set to “Anneal” mode to ensure zero surface penetration.
Step 3: Post-Marking Passivation
The instrument is placed in a Citric or Nitric Acid bath. This step is critical. The acid removes free iron from the surface and reinforces the chromium oxide layer. If the laser mark was done correctly (Annealed), the mark will remain black and vibrant after the acid bath. If it was “engraved,” the mark may turn gray or show signs of rust.
Step 4: Verification (The 2D DataMatrix)
Use a UDI-compliant barcode verifier to ensure the DataMatrix meets ISO/IEC 15415 standards (Grade B or higher).