Diagnostic Device Manufacturing Services

Full-scale cGMP and ISO 13485 compliant manufacturing services for in vitro diagnostic products. Supports formulation, fill, finish, and distribution from concept to commercial scale.

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

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

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

Full-scale contract manufacturing services for medical devices from prototype development through large-volume production including assembly and sterilization.

In vitro diagnostic contract manufacturing services for diagnostic reagents and assay components under ISO13485 quality standards.

Contract manufacturing services for in vitro diagnostic reagents and testing products. These services support development and production of diagnostic solutions for clinical use.

Quality management services ensuring ISO 13485 and FDA QSR compliance throughout medical device manufacturing. Integrated into comprehensive contract manufacturing solutions.

Custom diagnostic product development services for medical device companies and healthcare organizations. Leverages in-house expertise in autoimmune, infectious and therapeutic testing assays. Operates under ISO 13485:2016 quality standards with full documentation and validation support.

Full-service contract manufacturing for medical device companies covering development, approval, production, and sterile packaging. Supports complete value chain from concept to clinical delivery.

Contract development and manufacturing services for IVD instruments and consumables, providing end-to-end solutions from design to production. Operates multiple GMP-certified manufacturing facilities across Asia and North America. Supports clinical diagnostics companies with scalable, validated manufacturing processes.