The Laser Marking Opportunity: Why Now?
Three forces are driving demand for laser marking services right now: 1. Traceability regulations are tightening globally. From FDA Unique Device Identification (UDI) for medical devices to aer...
Industry Insights & Technical Guides
Stay updated with the latest in laser marking technology, industry trends, and product innovations
Expert insights on laser marking technology, application guides, industry trends, and product updates from IDEEDA's engineering team with over a decade of laser expertise.
How to Start a Laser Marking Business: Equipment, Costs & Tips
Primary Keyword laser marking business U...
6. Common Compliance Pitfalls
Pitfall 1: Deep Engraving on Surgical Instruments As the opening story illustrated, deep engraving on surgical steel creates crevices that compromise both sterility and mark durability. Fix: Use…
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…
4. Laser Parameters for Surgical Instrument Marking
Annealing Parameters for Stainless Steel (SS316/SS304) Parameter 20W Fiber 30W Fiber Power (%) 40–55% 30–45% Speed (mm/s) 250–400 350–550 Frequency (kHz) 20–50...
3. Sterilization-Proof Marking Techniques
This is where most marking failures originate. The right mark type must survive the specific sterilization method your device encounters. Mark Types and Sterilization Survival Mark Type A...
2. DataMatrix Code Specifications for Medical Devices
The 2D DataMatrix (ECC 200) is the standard AIDC format for medical device UDI marking. Code Size and Cell Specifications Parameter Standard Application Small Instruments Code size ...
1. What Is UDI and What Does the FDA Require?
UDI Structure A UDI consists of two parts: Device Identifier (DI): A fixed code identifying the device's version/model (assigned by an FDA-accredited issuing agency like GS1 or HIBCC)…
Laser Marking for Medical Devices: UDI Compliance & Best Practices
In September 2023, a surgical instrument manufacturer received a warning letter from the FDA: their UDI marks on reusable forceps were unreadable after the hospital's standard autoclave cycle.…
Laser Marking for Medical Devices: UDI Compliance & Best Practices
Primary Keyword laser marking medical devices ...