· Compliance Safeguard
· End-to-End Empowerment for Medical Innovation
Core Capabilities
Precision Manufacturing System
Fully automated injection molding/machining production lines with 0.01mm precision control, meeting Class II/III device production requirements
Material Compliance Assurance
Global medical-grade material database established, providing biocompatibility verification + material traceability system
Rapid Prototyping Development
3D printing/CNC rapid prototyping, first version delivered within 72 hours, supporting design iteration and optimization
Sterilization & Packaging Solutions
EO/radiation sterilization validation, customized primary packaging solutions compliant with FDA/CE/MDR requirements
Registration & Submission Support
Dedicated team providing technical documentation preparation, testing agency coordination, and clinical evaluation support
Continuous Cost Reduction Services
Full lifecycle cost control achieved through DFM analysis, supply chain optimization, and process improvement
Industry Solutions
Diagnostic Equipment ODM
Custom development of POCT devices/IVD instruments/biosensors
Case Study:
Achieved 99.2% production yield for a molecular diagnostic device
Minimally Invasive Interventional Devices
Precision machining of catheters/stents/trocars
Specialty:
Nitinol laser cutting + surface modification technologies
Smart Medical Hardware
System integration for wearables/remote monitoring products
Services:
PCB design + embedded development + APP synchronization
Disposable Packaging Solutions
Sterile blister packs/self-sealing bags/Tyvek® packaging
Certification:
ISO 11607-1/-2 dual-certified production lines
Quality Assurance System
01
Design Input
02
Risk Control
03
Process Validation
04
Batch Traceability
Implemented through QMS system:
Real-time Electronic Batch Record (EBR) monitoring
21 CFR Part 11 compliant data management
Annual mock audit mechanism
In-House Factory Capabilities
12,000m² Class 100K Cleanroom
• 16 dedicated medical device production lines
• Real-time monitoring of temperature/humidity/differential pressure
Precision Manufacturing Cluster
• 0.005μm precision wire-cut EDM (for cardiac stents & minimally invasive devices)
• 5-axis synchronized precision molding (single-cycle molding of complex components)
• Automated laser welding (hermeticity up to 10-⁹ Pa·m³/s)
Quality Inspection Lab
Equipped with 48 testing instruments including CMM, SEM, FTIR spectrometer
Collaboration Process
01
Requirement Analysis
02
Solution Customization
03
Contract Review
04
Project Launch
05
Phased Delivery
NPI project management platform provided
Visual tracking of critical milestones
Customer Testimonial
Supply Chain Director
Medical equipment listed company
Supply Chain Director
Medical equipment listed company
Supply Chain Director
Medical equipment listed company
FAQ
Minimum order quantity for custom parts?
Capabilities for special material processing?
Quality assurance for cross-industry machining?
Compared to traditional CNC machining, what are the advantages of 3D printing?
Do you support mass production of metal functional parts?
CONTACT US
Xinrui Medical Innovation Center, Bashankou Village, Sandong Town, Huicheng District, Huizhou City, Guangdong Province