· 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





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?