ISO 13485 Certified

Life-Saving Electronics.
Manufactured with Precision.

Your trusted medical electronics manufacturing partner in Shenzhen. From PCBA prototypes to full device assembly — every board we ship meets the standards your patients depend on.

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Medical electronics clean room SMT manufacturing facility
ISO 13485:2016
FDA Registered
CE MDD / MDR
IPC-A-610 Class 3
ISO 14971 Risk Mgmt (Compliance)
Core Capabilities

Medical Electronics Portfolio

Precision-manufactured PCBA and modules for Class I, II, and III medical devices. Every product line is supported by full traceability and device master record documentation.

Patient Monitor PCBA mainboard assembly

Patient Monitor PCBA

Multi-parameter mainboard assemblies supporting ECG, SpO2, NIBP, and temperature channels with isolated power domains.

Pulse Oximeter sensor module PCB assembly

Pulse Oximeter Modules

Miniaturized SpO2 sensor boards with red/IR LED drivers, photodiode front-ends, and motion-tolerant signal processing.

ECG Front-End acquisition board for 12-lead monitoring

ECG Front-End Boards

12-lead acquisition with right-leg drive, Wilson central terminal, and ultra-low-noise instrumentation amplifiers.

Infusion Pump control board with dual-MCU safety architecture

Infusion Pump Control

Stepper motor drive boards with occlusion detection, air-in-line sensing, and dual-microcontroller safety architecture.

Ventilator turbine and solenoid control board assembly

Ventilator Electronics

Turbine/blower control, proportional solenoid valve drivers, flow/pressure sensor interfaces with redundant safety monitoring.

Wearable biosensor board with PPG and bio-impedance sensors

Wearable Health Sensors

Flex and rigid-flex biosensor assemblies: PPG, bio-impedance, temperature, and IMU for continuous ambulatory monitoring.

EMS therapy pulse generator and isolated output stage PCBA

EMS Therapy Devices

High-voltage pulse generation, isolated output stages, and programmable waveform synthesis for TENS/NMES/IFC modalities.

Diagnostic imaging AFE and detector readout board assembly

Diagnostic Imaging Boards

Ultrasound front-end AFEs, X-ray detector readout, and MRI gradient amplifier modules with low-noise analog design.

10K
Clean Room Class
15yr
Medical EMS Heritage
8+
SMT Lines Certified
6
ISO & Regulatory Certs
Manufacturing Excellence

Clean Room Manufacturing: ISO Class 7 (Class 10,000)

All medical-grade assemblies are produced in our certified clean room environment with continuous particle monitoring, positive pressure control, and HEPA filtration. Temperature and humidity are maintained within tightly controlled bands to ensure consistent solder paste rheology and component integrity.

  • Continuous particle counting
  • ESD-protected throughout
  • Temperature 22 +/- 2 degrees C
  • RH 45 +/- 5%
  • HEPA 99.97% at 0.3 micron
  • Positive pressure cascade
By the Numbers

Operational Vital Signs

Real-time indicators of our manufacturing performance and quality commitment.

First-Pass Yield
99.2%
On-Time Delivery
97.8%
Annual PCBAs
2.4M+
Defect Rate (DPPM)
<50dppm

Ready to Discuss Your Medical Device Electronics?

Start with a mutual NDA. Tell us about your device classification, target market, and development stage — we will respond with a tailored manufacturing proposal within 24 hours.

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