SpiTrex SWI (Switzerland)
+41 32 552 10 00
Girardet 292400
LeLocle, Switzerland
SpiTrex SWI Process
Certified, Proven & Purpose-Built for Orthopedic Manufacturing
At SpiTrex SWI, our manufacturing process is designed to meet the various demands of the orthopedic industry — combining engineering expertise, validated systems and a deeply embedded culture of quality. From initial design collaboration to final inspection, every step is aligned with globally recognized standards and regulatory expectations, including ISO 13485 certification and FDA registration.
As part of the SpiTrex Group, we draw on decades of CNC machining experience, enhanced by additive manufacturing capabilities and advanced inspection technologies. This hybrid approach allows us to tailor our processes to your project needs, whether through co-design, standalone CNC production or an integrated additive workflow.
OEM-Level Quality, Delivered at Every Stage
ISO 13485 Certified
Our quality management system is ISO 13485 certified, as we meet stringent regulatory requirements while maintaining consistent, high-quality output.
FDA Registered Facility
SpiTrex SWI is FDA registered and has passed rigorous audits that validate our processes, equipment and compliance procedures.
Validated Equipment & Cleaning Protocols
All manufacturing and cleaning equipment is validated to meet the strict cleanliness and sterility expectations of the medical device industry.
CMM & Vision System Inspections
With Zeiss Coordinate Measuring Machines (CMM) and advanced vision systems, we verify dimensional accuracy and eliminate the risk of part mix-ups before shipment.
First Article Inspections (FAI)
Every new part undergoes First Article Inspection to confirm it meets exact design specifications before moving into production.
Co-Design & Process Integration
What sets our process apart is our ability to integrate engineering support from Day 1. Through collaborative design reviews, DFM (Design for Manufacturability) input and real-time problem-solving, we help streamline development while making certain your parts are production-ready from the outset.