Medical Device Laser Marking · Twin Cities, MN
We handle the marking, the First Article Inspection, and the paperwork. You get marked parts plus the documentation your DHR requires — without buying a laser or hiring an operator.
Same-business-day quotes. FAI included. CoC available on request.
We work like your anodizer or powder coater — you send parts, we process them, you get them back. The difference is we also send back the documentation your quality team needs.
Upload a PDF, DXF, STEP, or any standard CAD format. Include the material, mark type (Data Matrix, human-readable text, logo), mark location, and annual quantity estimate. If you have a spec or a UDI requirement, attach it.
No drawing yet? A photo and a description is enough to get a ballpark.
We review your drawing and respond same business day with a firm quote — unit price, setup fee if any, and lead time. The quote is what you'll pay. No surprises on the invoice.
Questions about compliance or process? We'll answer those in the same response.
Send your parts to our Eden Prairie facility. We accept UPS, FedEx, and freight. For first-time orders we'll mark a First Article before running the full lot — and we'll send you photos for approval before proceeding.
Rush turnaround available. Ask when you request the quote.
We ship your marked parts back with a First Article Inspection report. Certificate of Conformance is available on request — useful for your DHR and supplier qualification records. Parts are marked to your drawing, inspected, and ready to go into your assembly.
Need ongoing production runs? We keep your program on file.
Laser marking a medical device isn't just about the mark. It's about being able to prove what was marked, on what, and when. We build that paper trail into every order.
Included on every order. We mark one part first, inspect it against your drawing, and document the results. You get a report showing the mark dimensions, location, contrast, and readability before the full lot runs.
Available on request at no additional charge. States that the parts were marked per your drawing and specification. Suitable for inclusion in your DHR and supplier qualification file.
We retain order records including drawing revision, material, process parameters, and lot quantity. If you need to trace a marking back to a production run, we can support that.
We are not currently ISO 13485 certified, though we follow its principles and are working toward formal certification. If your supplier qualification requires a certificate, ask us — we'll be direct about what we can support.
A dedicated MOPA fiber laser system costs $50,000–$100,000. Add operator training, process validation, and ongoing maintenance — and it's a significant capital commitment for a function that isn't your core business.
Using a service bureau works exactly like outsourcing anodizing or powder coating. You send parts, we process them, you get them back. The marking process is validated on our end. You pay per part, not per year.
For most medical device manufacturers marking under 50,000 parts per year, outsourcing costs less than in-house — even before accounting for validation and operator time.
Upload your drawing or spec and we'll respond same business day with a firm quote, lead time, and answers to any compliance questions.
Or call: (612) 446-5488
