The Lujian Technology & Sichuan Innovation CDMO platform is a high-end medical device full-chain empowerment system, collaboratively built with regulatory, quality, R&D transformation, and industrialization capabilities. The core team has over 10 years of experience in Class III device process development, pilot-scale expansion, and mass production conversion.

1. High Barriers for Class III Devices: Focused on High-Value Consumables and Conquering Global Innovation Projects

Technological Strength Verified Globally

International Standards: Undertakes the exclusive global Class III innovative device TroClose 1200, upgrading and iterating on the original technology, with the 2.0 version successfully obtaining FDA approval.

Breakthrough Key Processes: Clinically driven, with collaboration between domestic and international engineers, successfully completing technical iterations for Class III medical devices.

R&D Support: For non-standard production characteristics of high-value consumables, over ten sets of customized patent tools and fixtures are designed for single products, with a total of more than 20 core patents held.

2. Global Compliance: FDA Certification + Dual Contracts, Establishing Strong International Entry Barriers

Product Registration: Multiple products have passed FDA 510(k) registration, strictly adhering to QSR 820 regulatory requirements, and have gained access to major global markets, including the US, Europe, and Japan.

Production Compliance: With over 10 million yuan invested in hardware, the platform has achieved ISO13485 quality system certification, meeting core requirements for sterile control, sterilization process verification, and process validation (PV) for Class III devices. It fully complies with FDA/GMP standards.

Dual Qualifications: One of the few in China with integrated "production + sterilization" compliance capabilities, holding both global contract manufacturer and contract sterilizer statuses, avoiding compliance risks and cycle delays associated with outsourcing sterilization.

3. Full-Chain Services: From Concept to Market, Closed-Loop Solutions for Transformation Pain Points

Service Closed-Loop: Offers a comprehensive service from regulatory consultation (NMPA/FDA/CE pathway planning) → process design and development (DFM optimization) → clinical sample production (small-batch pilot) → registration filing (document preparation + review follow-up) → large-scale mass production → product iteration and optimization, delivering a one-stop solution for "concept to compliant market release."

Collaboration Matrix: Has undertaken over 10 domestic and international projects, collaborating with top-tier public hospitals, research institutions, and innovation teams from the US, Israel, and South Korea, achieving “imported technology localization + domestic technology globalization” for two-way implementation.

Custom Efficiency: For startup device companies and research institutions, provides customized solutions for “small-batch pilot + rapid registration,” reducing Class III device time-to-market by more than 30%.