We support our customers' competitiveness and contribute to improving patients’ ultimate experience by creating reliable and technologically advanced products with care. At our nine ISO 13485 certified factories, we can manage your projects from low-mix high-volume to low-volume high-mix, putting our expertise and approach to regulatory compliance standards to serve our customers’ products. From personal healthcare to diagnostic equipment, improving patients’ experience by delivering high-quality engineering and manufacturing services matters to USI.
Experience
Working with world-leading medical brands from design to manufacturing product across various domains, including Personal Healthcare, Patient Monitoring and Diagnostic Equipment. Our experts come from different field like design, engineering, tooling, injection molding, and supply chain management. We are here to accelerate your business and create a Win-Win solution together.
Regulations & Standards
We support our customers with FDA Registration and offer RUO (Research Use Only) and IVD (Investigational Use Only) support. We manufacture products that are Creating Quality for Life.
- ISO 9001
- ISO 13485
- ISO 14001
- FDA Class II
- 21 CFR Part 820
- CE Mark
With ISO 9001, ISO 13485, ISO 14001, FDA Class II, 21 CFR Part 820, CE Mark
With ISO 9001, ISO 13485, ISO 14001