Services & Capabilities
Contract Development & Manufacturing Solutions
• End-to-end solutions from design to market
• Support for both medical and non-medical applications
Material Formulation
• Design verification and feasibility studies
• Custom product development and innovation
Manufacturing Capability
• Cleanroom manufacturing (Class 100,000 / ISO 8)
• Multi-material extrusion and molding
• Auto-assembly production lines
Quality Capability
▸ Verification & Validation Capability
• Product testing and functional evaluation
• Biocompatibility and shelf-life testing
• Design validation protocols
▸ Registration Capability
• Support with CE, FDA, NMPA, and global filings
• Dossier preparation and submission
• Technical documentation and labeling
▸ QMS Capability
• ISO 13485-certified quality systems
• CAPA, audit readiness, risk management
• Traceability, batch control, and documentation
▸ Small Trial Capability
• Rapid prototyping
• Limited batch production for testing or market trials
• Steam Sterilization (Autoclave)
Sterilization Capability
• Gamma Sterilization
• EO (Ethylene Oxide) Sterilization
• EBM (Electron Beam) Sterilization
Tooling Capability
• In-house mold/tool design and fabrication
• Tool validation and maintenance
• Rapid tooling for short-run products
Global Supply Chain &
Logistics Capability
• Worldwide delivery and shipping support
• Cold chain and sterile packaging logistics
• Vendor-managed inventory and warehousing
Auto Assembly Capability
• Semi-automatic and fully automatic assembly lines
• Assembly under controlled conditions (cleanroom, dry room)
• Custom automation for complex product builds
Project Management Capability
• Cross-functional coordination from concept to commercialization
• Timeline tracking, resource management, and risk mitigation
• Client-focused communication and reporting systems