ISO 13485 Certified Medical Device Manufacturing

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

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

Contract manufacturing services for medical devices from prototype through high-volume production. Provides design-to-production support with ISO 13485 compliance and regulatory expertise.

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.

Full manufacturing services for diagnostic devices including production control, validation, and quality assurance under ISO13485 standards.

Controlled sterile manufacturing environment certified ISO 7 and ISO 13485 for production of medical-grade plastic components with validated sterilization and quality assurance protocols.

EN ISO 13485-certified contract manufacturing of medical devices from prototype to production, supporting both startups and established manufacturers.

Contract manufacturing services for medical devices including design, production, and quality assurance. Operates in certified facilities meeting medical device manufacturing standards and regulatory requirements.

Full-service manufacturing solutions for national tenders and private medical device production setups, delivering ISO-certified quality products.

Scalable manufacturing services for complex medical devices with regulatory compliance and quality assurance. Supports production from prototype to full commercial scale.

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-service manufacturing of sterile medical devices and in vitro diagnostic medical devices. Services include design, tooling, injection molding, sterilization, and assembly.