We hold ISO 13485 certification, confirming our consistent compliance with medical device regulations and customer expectations. Our cleanroom facility complies with the ISO Class 6, 7, and 8 requirements. We also follow strict policies, procedures, and change processes that are aligned with the 21 CFR Part 820 regulations that ensure our QMS is well-documented, controlled, and audited.
In addition, we have implemented a comprehensive quality assurance program that covers every stage of our production process:
- Internal Metrology and Calibration
- Scalable Quality Inspection Equipment
- Inspections
- Validations (IQ/OQ/PQ)
As a global supplier of plastic injection molding and medical device manufacturing services, we also support our customers with regulatory documentation used for submissions, such as DMF, 510(k) and CE marking, providing expertise in technical documentation, risk management, and conformity assessments to demonstrate product safety and effectiveness.
