Our quality management system conforms to ISO 13485 for the manufacture, servicing, and traceability of medical device components.
Quality & compliance
Quality & Documentation for Regulated Machined Parts.
We build to the standard your industry is held to — and document every step, so your quality team never has to chase us.
A quality system conforming to ISO 9001 governs every order, from contract review and document control to corrective action.
Material certifications, lot traceability, and inspection records on every order.
Registered with the FDA since 2004, manufacturing and servicing medical devices under current good manufacturing practice.
Quality manual and supporting documentation available on request. Ask for our quality pack.
How we inspect Quality isn't a department.
Quality isn't a department.
It's every step.
- 01
Contract review
Requirements, specs, and flow-downs confirmed before a chip is cut.
- 02
In-process checks
Operators verify critical features at the machine, every run.
- 03
Final inspection
CMM and optical inspection against the print and inspection plan.
- 04
Documentation
Reports, certs, and traceability packaged with your shipment.
Documentation
Every part ships with the proof.
First Article Inspection
Full dimensional FAI on every new part number and revision.
PPAP packages
Production part approval documentation on request.
Certificates of conformance
Signed C of C shipped with every order.
Material certifications
Mill certs and full lot traceability back to heat.
Inspection reports
CMM and optical measurement data for critical characteristics.
Validation support
IQ/OQ/PQ support for regulated medical programs.
Request a quote Send us your print.
Send us your print.
Get a real answer.
Our engineers review every drawing for manufacturability and return a detailed quote — typically within 48 hours. Confidential, with an NDA on request.
- NDA on request
- DFM feedback included
- Direct line to an engineer