ISO 13485 certified facility with biocompatible materials, cleanroom capabilities, and complete regulatory documentation support.
From surgical instruments to implantable devices, we provide precision manufacturing with full regulatory support
Ultra-tight tolerances (±0.01mm) for surgical instruments and medical device components
Medical-grade stainless steel, titanium, PEEK, and USP Class VI plastics with certifications
ISO Class 7 cleanroom for sterile and implantable device production
Design history files, DHRs, IQ/OQ/PQ protocols, and FDA submission support
Full traceability, validation, and quality control per ISO 13485 requirements
Medical-grade packaging and sterilization coordination (EtO, gamma, autoclave)
Biocompatible materials with complete certifications and test reports
Trusted by medical device manufacturers worldwide
Work with an ISO 13485 certified partner for your next medical device