ISO 7 Certified Cleanroom Manufacturing

Specialized manufacturing services for medical and pharmaceutical products in cleanroom environments meeting ISO 13485 and GMP standards. Includes production, assembly, sterilization, and quality control.

Full-scale manufacturing capabilities for sensor-integrated medical components in ISO 13485-certified facilities with ISO Class 7 clean rooms. Supports production from early prototyping through commercial scale.

GMP-compliant cleanroom manufacturing facility with internalized industrial processes for sterile and non-sterile medical device production.

Full-service medical device manufacturing with ISO 13485 certification, MDR compliance, and cleanroom production ensuring regulatory traceability and quality assurance.

Contract manufacturing services for medical devices including protective garments with capacity of 15.6 million units annually in ISO Class 100,000 cleanroom facilities. Certified under ISO 13485 quality management system.

Contract manufacturing services operated under ISO 13485 quality management systems for medical device production and compliance.

Contract manufacturing services for sterile and active medical devices in cleanroom environments. Provides Class II and III medical device production with dual traceability systems for regulatory compliance.

Full-scale production services for sterile medical device packaging using class 10,000 cleanroom facilities. Includes quality control testing and compliance with medical packaging standards.

Manufacturing and assembly services for medical components performed under cleanroom conditions to ensure sterility and precision for implantable and invasive medical devices.

Cost-effective clean room production services for disposable medical devices meeting strict manufacturing standards.

Expert design and construction of sterile and clean manufacturing facilities compliant with FDA, GMP, and ISO 14644 standards for pharmaceutical and medical applications.

Classification and validation testing for sterile manufacturing environments, ensuring compliance with contamination control requirements for medical device production.