High-Reliability Medical Device PCBA Electronics PCB Assembly
SZH has its own fully self-contained production plant with several high-precision SMT lines at the core, and additionally DIP, testing, and assembly lines. Thus, they can provide flexible manufacturing from prototype up to mass PCB assembly.
High-Precision SMT Lines: Able to mount 01005 components, 0.3mm pitch BGA, QFN, and other fine-pitch packages.
Complete Process Coverage: SMT double-sided, mixed assembly, selective soldering, and press-fit technology are all included.
Strict Quality Control: Inspection throughout the whole process with SPI, AOI, X-Ray, functional testing, and aging test systems.
- SZH
- China
- Information
1. Product Overview
A high-reliability PCBA specifically designed for medical devices. This product integrates precision electronic manufacturing, stringent quality control, and medical-grade compliance, making it suitable for critical medical applications such as life support, monitoring, diagnosis, and treatment equipment.
2. Core Features
High-Reliability Design and Manufacturing
High-reliability design and manufacturing: Featuring redundant circuit design with ESD (electrostatic discharge) and EMC (electromagnetic compatibility) protection.
Conformal coating technology (moisture-proof, corrosion-resistant, and dustproof).
Hybrid process technology combining high-precision SMT and THT (through-hole technology) assembly.
End-to-end Quality Control
IQC for all components
AOI and X-Ray solder joint inspection
ICT and FCT
ESS, aging tests, and reliability validation
Traceability and Documentation Support
Provides a comprehensive serialization solution for full production traceability
Complete Device History Records, test reports, and compliance documentation
Supports customized documentation and validation schemes (e.g., required for FDA 510(k) submissions)
3. Technical Specifications (Customizable per Requirements)
| Parameter | Specification Details |
|---|---|
| Board Type | High-Tg FR-4, Aluminum Base, Ceramic Substrate, Flexible PCB |
| Component Packages | Capable of accommodating 01005, micro-BGA, QFN, CSP, etc. |
| Operating Temperature | -40°C to +125°C (Extendable range available) |
| Protection Level | Optional IP54-IP67 rated conformal coating |
4. Typical Application Scenarios
Life Support Devices: Ventilators, cardiac pacemakers, infusion pumps.
Monitoring and Diagnostic Equipments: Electrocardiographs (ECGs), patient monitors, blood glucose meters.
Medical Imaginge Equipments: Portable ultrasound devices, endoscope control units.
Therapeutic Equipments: Laser therapy systems, rehabilitation devices, dialysis machines.
Laboratory Instruments: In vitro diagnostic (IVD) systems, PCR systems, centrifuges.
5. Service and Production Workflow
Requirement Analysis – Review of customer specifications, schematics, layout files.
Design Optimization – DFM/DFA analysis and medical compliance review.
Prototyping Development – Rapid prototyping for Engineering Verification Testing (EVT).
Trial Run and Testing – Design Validation Test (DVT) and Process Validation (PV).
Batch Production – Full traceability and on-time delivery.
Post-Production Support – Continuous supply chain management, change management, and Failure Analysis (FA).
6. Why Choose Our Medical PCBA?
Proven Professional Expertise – With over a decade of deep expertise in medical electronics manufacturing, serving globally renowned brands.
Strict Environmental Control – Equipped with 10K/100K cleanrooms and comprehensive Electrostatic Discharge (ESD) protection systems.
Reliable Supply Chain – Strategic partnerships with medical-grade component OEMs (e.g., Texas Instruments, Agilent, Murata).
End-to-End Compliance System – Strict adherence to medical quality management systems from design to shipment.
Rapid Response Support – Capable of emergency order processing and flexible production scheduling.
7. Request a Customized Quote
Submit your project requirements to receive a free design review and cost optimization plan, prototype delivery timeline, compliance certification guidance, and a detailed mass production quote.
