High-Reliability Medical Device PCBA Electronics PCB Assembly
SZH operate a fully self-owned production base equipped with multiple high-precision SMT lines, complemented by DIP, testing, and assembly lines. This enables flexible production from prototyping to large-scale PCB assembly.
High-Precision SMT Lines: Support 01005 components, 0.3mm pitch BGA, QFN, and other fine-pitch package assembly.
Full-Process Coverage: Including double-sided SMT, mixed assembly, selective soldering, and press-fit technology.
Rigorous Quality Control: Full-process inspection with SPI, AOI, X-Ray, functional testing, and aging test systems.
- SZH
- China
- Information
1. Product Overview
A high-reliability PCBA (Printed Circuit Board Assembly) engineered specifically for medical devices. It integrates precision electronics manufacturing, stringent quality control, and medical-grade compliance, making it suitable for critical medical applications such as life support, monitoring, diagnostic, and therapeutic equipment.
2. Core Features
✅ Medical-Grade Compliance & Certification Support
Compliant with ISO 13485 Medical Device Quality Management Systems
Adheres to IEC 60601-1 Safety Standards for Medical Electrical Equipment
Supports RoHS, REACH Hazardous Substance Restrictions
Offers material selection & process validation support for biocompatibility
✅ High-Reliability Design & Manufacturing
Utilizes medical-grade materials: High-Tg FR-4, Ceramic substrates, or Flexible PCBs
Implements redundant circuit design, ESD & EMC protection
Features conformal coating (anti-moisture, corrosion, dust) application
Employs mixed-technology processes: High-precision SMT & THT assembly
✅ Full-Process Quality Control
Incoming Quality Control (IQC) for all components
Automated Optical Inspection (AOI) & X-Ray solder joint inspection
In-Circuit Test (ICT) & Functional Circuit Test (FCT)
Environmental Stress Screening (ESS), Burn-in Testing & Reliability Validation
✅ Traceability & Documentation Support
Unique serialization for full production traceability
Complete DHR (Device History Record), test reports, and compliance documentation
Supports custom documentation & validation packages (e.g., 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 |
| Layers | 1-20 Layers (HDI Capable) |
| Min. Trace/Space | 0.075mm / 0.075mm |
| Surface Finish | ENIG, Immersion Silver, OSP, Electrolytic Gold Fingers |
| Component Packages | Supports 01005, micro-BGA, QFN, CSP, etc. |
| Soldering Process | Lead-Free Reflow, Nitrogen-Assisted Soldering |
| Operating Temperature | -40°C to +125°C (Extendable range available) |
| Protection Level | Optional IP54-IP67 rated conformal coating |
4. Typical Applications
Life Support Equipment: Ventilators, Pacemakers, Infusion Pumps
Monitoring & Diagnostics: ECG Machines, Patient Monitors, Glucose Meters
Medical Imaging: Portable Ultrasound, Endoscope Control Units
Therapeutic Devices: Laser Therapy Systems, Rehabilitation Equipment, Dialysis Machines
Laboratory Instruments: In-Vitro Diagnostics (IVD), PCR Systems, Centrifuges
5. Service & Production Workflow
Requirement Analysis – Review of customer specs, schematics, layout files.
Design Optimization – DFM/DFA analysis & medical compliance review.
Prototyping – Rapid prototyping for Engineering Validation Test (EVT).
Pilot Run & Testing – Design Validation Test (DVT) & Process Validation (PV).
Volume Manufacturing – Full traceability and on-time delivery.
Post-Production Support – Sustained supply chain, change management, FA.
6. Why Choose Our Medical PCBA?
Proven Expertise – Over 10 years in medical electronics manufacturing, serving global brands.
Controlled Environment – Class 10K/100K cleanrooms with full ESD control.
Reliable Supply Chain – Partnerships with medical-grade component OEMs (e.g., TI, ADI, Murata).
End-to-End Compliance – Strict adherence to medical QMS from design to shipment.
Responsive Support – Emergency order capability and flexible production planning.
7. Request a Custom Quote
Share your project requirements to receive:
A free design review & cost-optimization proposal
A prototype delivery timeline
Guidance on compliance & certification pathways
A detailed volume production quotation
