Manufacturing

Cleanroom Environment
 

• Class 100,000 (ISO 8) cleanroom designed for medical device manufacturing.
• Maintains strict particulate and contamination controls to ensure product quality and patient safety.
• Positive pressure system with HEPA filtration for critical processes.
• Dedicated gowning and material entry protocols to protect product integrity.
   

Controlled Room
 

• Temperature regulated environment to support sensitive processes. 
• Suitable for secondary assembly, packaging, and storage of medical products.
• Continuous monitoring systems.
   

Regulatory Certifications
 

• ISO 13485 certified by BSI.
• FDA registered and cGMP compliant.
• SFDA listed.
   

Testing & Laboratory Facilities
 

• In-house lab for raw material verification and product quality control.
• Equipped for performance validations and bio testing.
• Supports accelerated aging studies and validation of packaging integrity.
   

Prototyping & Development Capabilities
 

• Rapid prototyping tools for new product concepts and custom designs.
• Pilot-scale production lines to bridge R&D and full-scale manufacturing.
• Cross-functional engineering and quality teams to support innovation and regulatory requirements.
   

Manufacturing & Quality Systems
 

• Lean manufacturing processes optimized for efficiency and traceability. 
• QMS ensures compliance across all operations.
• Dedicated inspection and release areas to meet customer specifications and regulatory requirements.

We are committed to delivering high-quality, innovative medical products and solutions. As your trusted partner, we bring expertise across a broad range of capabilities, including:

Advanced Converting & Customization

• High-precision converting technologies for tailored product designs and unique customer requirements.
   

Ultrasonic and RF Welding

• Expertise in secure, reliable bonding solutions that enhance product durability and performance.
   

Assembly Services

• Semi-finished and finished product assembly with rigorous quality control at every stage.
   

Packaging Solutions

• Flexible pouch and blister packaging options designed for safety, sterility, and regulatory compliance.
   

Printing Services

• Comprehensive printing capabilities for labeling, branding, and regulatory information.
   

Process Control & Validation

• End-to-end process management, with strict validation protocols to ensure consistency and compliance.
   

Sterilization Support
 

• Sterilization validation and management to meet global standards and safeguard product integrity.

  We combine innovation with precision to deliver medical products you can trust. From customized converting, ultrasonic, RF welding to assembly, packaging, and sterilization support, our facilities and processes are designed to meet the highest global standards. With end-to-end process validation and quality management, we’re here to be your partner in bringing safe, effective medical solutions to market.