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XZT Electronics provides one-stop supply chain services of "medical-grade electronic components + high-precision PCB/PCBA" for medical device manufacturers, medical equipment R&D enterprises and healthcare technology suppliers. Covering the full-cycle support from R&D prototyping to mass production, we fully meet the stringent requirements of medical devices for precision, reliability, biocompatibility and regulatory compliance.
Our products strictly comply with international medical industry standards such as ISO 13485 quality management system, FDA (U.S.), CE MDR (EU) regulations, ISO 14971 risk management requirements, and ISO 10993 biocompatibility standards, as well as RoHS environmental protection norms. They feature high precision, low noise, stable performance and long service life, adapting to the sterile, high-reliability and strict quality control requirements of medical scenarios.
Core Application Scenarios
- Diagnostic Equipment: Ultrasound imaging system components, CT/MRI scanner control PCB/PCBA, blood glucose meters, biochemical analyzers, and diagnostic sensor signal processing modules;
- Monitoring Devices: ECG monitors, blood pressure monitors, pulse oximeters, patient monitors, and vital sign data acquisition PCB/PCBA;
- Therapeutic Equipment: Ventilators, infusion pumps, hemodialysis machines, laser therapy devices, and treatment parameter control PCB/PCBA;
- Portable & Home Medical Devices: Portable nebulizers, wearable health monitors, home oxygen concentrators, and low-power consumption PCB/PCBA for mobile medical products;
- Implantable Medical Devices: Miniaturized electronic components, biocompatible PCB assemblies for cardiac pacemakers, neurostimulators, and implantable sensors (compliant with strict biocompatibility and hermeticity requirements);
- Dental & Surgical Equipment: Dental imaging devices, surgical navigation systems, electrocautery machines, and sterile-grade control module PCB/PCBA.
Exclusive Service Advantages
- Regulatory compliance support: Providing complete certification documents (ISO 13485, FDA/CE MDR certificates) and traceability reports to assist customers in product registration and market access;
- High-precision customization: Offering miniaturized PCB design, low-noise circuit optimization, and high-density PCBA assembly to meet the compact and high-performance requirements of medical devices;
- Biocompatibility & sterility guarantee: Cooperating with certified suppliers to ensure components/PCBA meet ISO 10993 biocompatibility standards, supporting sterile packaging and sterilization process adaptation;
- Full-chain traceability: Implementing batch-level traceability management for raw materials, production processes and delivery, meeting medical device quality traceability requirements;
- Strict quality control: Conducting rigorous reliability testing (temperature cycle test, vibration test, long-term stability test) and sterile inspection to ensure product safety and consistency;
- R&D prototyping support: Providing professional technical consultation for medical device R&D, optimizing component selection and PCB/PCBA design to shorten R&D cycles.
