· Expert Manufacturing
· Compliance Safeguard
· End-to-End Empowerment for Medical Innovation
We provide global medical device companies with comprehensive OEM solutions from concept to mass production. Leveraging our ISO 13485/GMP certified systems, 10+ years of medical manufacturing expertise, and 200+ successful cases, we help reduce time-to-market by 40% and lower overall costs by 30%.

Core Capabilities

Precision Manufacturing System

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

Material Compliance Assurance


Global medical-grade material database established, providing biocompatibility verification + material traceability system

Rapid Prototyping Development

Rapid Prototyping Development


3D printing/CNC rapid prototyping, first version delivered within 72 hours, supporting design iteration and optimization

Sterilization & Packaging Solutions

Sterilization & Packaging Solutions


EO/radiation sterilization validation, customized primary packaging solutions compliant with FDA/CE/MDR requirements

Registration & Submission Support

Registration & Submission Support


Dedicated team providing technical documentation preparation, testing agency coordination, and clinical evaluation support

Continuous Cost Reduction Services

Continuous Cost Reduction Services


Full lifecycle cost control achieved through DFM analysis, supply chain optimization, and process improvement

Industry Solutions

Diagnostic Equipment ODM

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

Minimally Invasive Interventional Devices

Precision machining of catheters/stents/trocars

Specialty:

Nitinol laser cutting + surface modification technologies

Smart Medical Hardware

Smart Medical Hardware

System integration for wearables/remote monitoring products

Services:

PCB design + embedded development + APP synchronization

Disposable Packaging Solutions

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:

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Real-time Electronic Batch Record (EBR) monitoring

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21 CFR Part 11 compliant data management

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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

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NPI project management platform provided

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Visual tracking of critical milestones

Customer Testimonial

Xinrui's mold accuracy and medical grade quality control have increased the yield rate of our ventilator casings from 82% to 98%
Supply Chain Director

Supply Chain Director

Medical equipment listed company

Xinrui's mold accuracy and medical grade quality control have increased the yield rate of our ventilator casings from 82% to 98%
Supply Chain Director

Supply Chain Director

Medical equipment listed company

Xinrui's mold accuracy and medical grade quality control have increased the yield rate of our ventilator casings from 82% to 98%
Supply Chain Director

Supply Chain Director

Medical equipment listed company

customers
customers
customers
customers
customers

FAQ

Minimum order quantity for custom parts?

Orders start from 1 piece. For quantities under 50, we utilize our rapid prototyping line.

Capabilities for special material processing?

We've processed 217+ exotic materials including linconel 718 and silicon carbide-reinforced aluminum matrix composites

Quality assurance for cross-industry machining?

We implement IPC Class 3 inspection standards from medical/military sectors

Compared to traditional CNC machining, what are the advantages of 3D printing?

Complex structure integral forming, reducing assembly steps; 4096 improvement in materal utiization; 7096 reduction in delvery cycle

Do you support mass production of metal functional parts?

Supports metal printing (stainless steel/titanium alloys), Small-batch production capacity: 1,000 pcs/month