Medical Device Laser Marking · Twin Cities, MN
Data Matrix codes and human-readable text marked directly on the device. First article inspection included. Certificate of conformance available. Documentation to support your Device History Record.
Same-business-day quote response. First article inspection included.
UDI Requirements
FDA's Unique Device Identification (UDI) rule requires that most medical devices carry a permanent mark that includes a machine-readable code (Data Matrix is the standard) and human-readable text containing the device identifier and production identifier.
For Class II and Class III devices, direct part marking (DPM) — a mark applied directly to the device, not a label — is often required or strongly preferred because labels can be removed or damaged. Laser marking is the primary method for DPM on metal devices.
The mark must survive the device's expected lifetime, including sterilization cycles. On stainless steel and titanium, that means laser annealing — a process that requires MOPA technology, not standard fiber or CO2 lasers.
What We Provide
Why Outsource to Us
Running UDI marking in-house means buying a MOPA laser ($40K–$100K+), validating the process, training an operator, and maintaining the equipment. For most medical device OEMs and their machine shop suppliers, the volume doesn't justify that investment.
The service bureau model is the same as outsourcing anodizing or powder coating. Ship us your parts. We mark them to spec. Ship them back. Issue the PO with confidence — we produce documentation that goes straight into your DHR.
Marking is all we do. Your UDI job is our floor priority — not a side task squeezed in between machining runs.
Quote response on every request. Send your drawing today, get a number today.
Every new program. Verify the mark before production quantities run.
No surprise charges. What we quote is what you pay.
Get a Quote
Tell us about your device, material, and what the print calls out. Upload your drawing or spec sheet. We'll confirm the process and get you a quote the same business day.
Prefer to call? (612) 446-5488
