1、 Scenario positioning: Covering the full range of medical equipment OEM needs, we specialize in five core areas: high-value consumables, high-end imaging, life support, in vitro diagnostics, and rehabilitation equipment. We provide full process OEM services for medical equipment such as cardiac intervention products, orthopedic implants, CT/MRI components, ventilators, PCR detectors, etc., helping customers accelerate product launch and reduce compliance risks.


2、 Core solution: Six major services targeting pain points in the medical industry
1. Precision machining: dual guarantee of medical grade precision and biocompatibility
Scenario adaptation: Orthopedic implants (ceramic joints, spinal screws), surgical robot arms, imaging equipment detector modules
Technical highlights:
Tolerance control up to ± 0.0005in (Class III instrument standard), compatible with medical grade materials such as Ti-6Al-4V ELI titanium alloy and PEEK
Full batch material traceability (MTR certification), combined with UDI unique identification system, meets ISO 13485 Clause 4.2 document traceability requirements
Supporting high-precision processes such as microfluidic chips and laser engraving of vascular stents, adapting to the processing requirements of IVD equipment core components
2. Sheet metal processing: customized solution for clean grade structural components
Scenario adaptation: medical equipment casing, imaging equipment rack, rehabilitation equipment framework
Technical highlights:
Using 316L stainless steel and medical grade aluminum alloy, the anti-corrosion performance is improved through passivation treatment to meet the repeated use requirements in disinfection environments
Production in a 10000 level clean workshop to avoid dust pollution and comply with medical equipment cleanliness standards
Ergonomic structural design, suitable for the spatial layout of operating rooms and diagnosis rooms, supporting lightweight and radiation resistant customization
3. Surface treatment: dual breakthroughs in biosafety and durability
Scenario adaptation: implantable devices, disposable medical consumables, equipment contact surfaces
Technical highlights:
Biocompatible coatings: DLC diamond-like coating (low friction), HA hydroxyapatite coating (osseointegration), compliant with ISO 10993 and USP Class VI standards
Antibacterial and anti-corrosion treatment: Achieve an antibacterial rate of ≥ 99.9% and withstand 1000 cycles of high temperature and high pressure sterilization for surgical instruments
Diversified processes: PVD vacuum coating, electrochemical polishing, sterile passivation, suitable for differentiated needs of implanted/non implanted devices
4. Electrical R&D support: Medical grade electrical system integration solution
Scenario adaptation: ventilator control system, ECG monitor PCBA, AI diagnostic module
Technical highlights:
Compliant with ISO 13485+AMP5 standards, providing medical grade PCBA design, sensor integration, and embedded software verification services
Electromagnetic compatibility (EMC) optimization to meet the low interference requirements of medical equipment and adapt to multi device collaborative scenarios in operating rooms
Low power design and redundant backup ensure the continuous operation stability of life support equipment
5. Complete assembly OEM: full process control of whole machine OEM manufacturing
Scenario adaptation: complete in vitro diagnostic equipment, home rehabilitation equipment, portable diagnostic and treatment equipment
Technical highlights:
Implement the requirements of the new version of the "Medical Device Production Quality Management Specification" for "penetrative management" and establish a full process quality control system from material access to finished product release
Support small-scale trial production (to meet R&D iteration) and large-scale mass production (to cope with centralized procurement volume), with flexible production capacity to adapt to market demand
Including IQ/OQ/PQ process validation, providing complete equipment history records (DHR) to help customers quickly pass FDA/CE certification
6. Customization of finished products: on-demand research and development+integrated compliance landing services
Scenario adaptation: Innovative medical devices, personalized rehabilitation equipment, special diagnostic and treatment tools
Technical highlights:
Collaborate with clients to conduct product design risk analysis (ISO 14971) and mitigate compliance risks from the source
Provide full cycle services from prototype sampling, process validation to mass production delivery, reducing the time to market for innovative devices by over 30%
Customized processing requirements for new devices such as AI medical modules and brain computer interface sensors


3、 Compliance and Quality Assurance: Building a Strong Defense Line for Medical Safety
Qualification certification: ISO 13485 quality management system certification, in compliance with the commissioned production requirements of the new version of the "Medical Device Production Quality Management Specification"
Risk management: Full process FMEA risk assessment, on-site supervision of key processes, closed-loop management of change control
Testing capability: equipped with biocompatibility testing, precision dimensional testing, electrical performance verification laboratory, supporting batch inspection
Global adaptation: Meet international regulatory requirements such as FDA 510 (k) and EU MDR, and help products go global


4、 Collaboration Value: Becoming a Reliable Manufacturing Partner for Medical Innovation
Compliance reduction: Full process compliance documentation support reduces the risk of quality responsibility for registrants
Technical empowerment: cross category engineering experience to solve core technical pain points such as precision machining and biocompatibility
Efficiency improvement: rapid response from R&D trial production to mass production delivery, adapting to the iteration of medical equipment and the demand for bulk procurement