Medical-grade manufacturing technologies for precision, cleanliness, and compliance.
A clear roadmap to success
RexMed provides critical manufacturing infrastructure to support OEMs and medical innovators throughout the device lifecycle. Our manufacturing technologies enable extrusion, assembly, testing, labeling, and packaging of Class I and II medical devices under validated cleanroom conditions. These capabilities are powered by rigorous documentation, operational flexibility, and full traceability.
CLEAN ROOM MANUFACTURING
ISO Class 8 clean environments for contamination control
Our cleanrooms serve as the foundation for all core manufacturing operations. Equipped with controlled temperature, humidity, and particulate filtration, these environments ensure the integrity of extrusion, assembly, testing, and packaging processes. All cleanroom workflows are fully monitored and integrated into our QMS.
Thermoplastic tubing for critical medical applications
We extrude medical-grade tubing in single-lumen, multi-lumen, and radiopaque configurations. Using materials like PVC, EVA, PE, and PP, we serve a wide range of clinical functions including infusion, urology, and nutrition. Our extrusion processes operate under ISO Class 8 cleanroom conditions, with dimensional tolerances and post-processing aligned to customer specifications.
Our cleanroom-based assembly lines integrate extruded tubing, bags, connectors, and film into finished sets and devices. We support both manual and semi-automated workflows for infusion systems, enteral and parenteral nutrition, and surgical kits—always under traceable and validated procedures.
We incorporate inline quality testing into our extrusion and assembly processes to detect deviations immediately. This includes dimensional inspection, visual checks, and pressure-based tests as required. Inline validation reduces variability, increases throughput, and ensures regulatory alignment.
Compliant identification and sterile-safe protection
We provide primary and secondary packaging for sterile and non-sterile devices. Our labeling solutions include lot and batch tracking. All packaging operations are executed within ISO Class 8 cleanrooms and validated for downstream sterilization when required.
