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We are proud to announce that Rayboen has officially obtained ISO 13485:2016 Medical Device Quality Management System Certification.
This milestone represents our continued progress in precision medical manufacturing, bringing our quality system in line with global medical standards.
What is ISO 13485?
ISO 13485 is the worldwide quality standard created specifically for medical device manufacturers.
Unlike generic quality standards, it enforces strict requirements for standardized production, risk management, full traceability and consistent quality. It serves as the key benchmark to assess a medical manufacturer’s professionalism and compliance.
Rayboen delivers one-stop custom solutions for precision medical plastic components and injection molds. Covering DFM analysis, mold design, fabrication, injection molding and final shipment, every step follows medical-grade specifications to ensure stable, compliant outputs.
What does ISO 13485 certification mean for us?
This is far more than a certificate. It is third-party validation that our daily operations meet international medical manufacturing requirements.
We integrate risk assessment, process records and quality checks into real production rather than just paperwork. The audit proves our procedures, documents and on-site controls are fully compliant, enabling us to reliably support global medical device projects.
More reliable guarantees for our customers
For our partners, ISO 13485 brings real confidence in cooperation.
When you work with Rayboen, your medical molds and plastic parts are produced within a controlled medical-grade system, with complete traceability of production and inspection records.
The ISO 13485 certification marks a new starting point for our quality management.
Moving forward, Rayboen will keep applying medical manufacturing standards, refining our processes and quality controls, and supplying global customers with stable, reliable and compliant precision molds and plastic components.
