Medical PCB Assembly Services
We deliver high-reliability PCB assembly solutions for medical applications where precision, safety, and traceability are essential. From prototype to mass production, every process is controlled to meet the strictest industry standards.
Medical-Grade Quality Control & Compliance System
In medical PCB assembly, certifications alone are not enough. What truly matters is how these standards are implemented throughout the entire manufacturing process.
Our quality system is built to ensure consistent reliability, full traceability, and strict process control at every stage.
ISO 13485–Driven Process Control
Our ISO 13485-certified system governs every step of production, from engineering review to final inspection, ensuring consistent and auditable quality.
IPC Class 3 Manufacturing Execution
We apply IPC Class 3 standards in real production, including soldering quality, inspection criteria, and workmanship control for life-critical applications.
Full Traceability in Every Batch
All materials, components, and processes are fully traceable, allowing complete tracking from incoming materials to finished products.
Compliance-Ready Material Control
All materials are RoHS compliant and managed under strict supplier control systems to ensure global regulatory compliance.
Capabilities
With 21 SMT production lines across China and Vietnam, we provide flexible manufacturing capacity for both prototyping and volume production.
- 15 SMT lines in China for high-efficiency production
- 6 SMT lines in Vietnam for supply chain diversification
- Fast ramp-up from prototype to mass production
① High-Precision Placement
Placement accuracy up to ±0.025mm Supports fine-pitch components including BGA and QFN Suitable for high-density medical PCB designs
② Stable & Controlled Reflow Process
Multi-zone reflow system with ±1°C temperature control Ensures consistent soldering quality Reduces thermal stress on sensitive components
③ Advanced Inspection System
3D Solder Paste Inspection (SPI) Automated Optical Inspection (AOI) X-ray Inspection for BGA/QFN Functional Circuit Testing (FCT) Reliability Testing Support
④ High-Reliability Assembly
IPC-A-610 Class 3 standard Designed for life-critical applications Strict defect control process
| Capability | Specification |
|---|---|
| Max PCB Size | 800 × 600 mm |
| Max Layer Count | Up to 14 layers |
| Min Component Size | 01005 |
| Fine Pitch Capability | 0.35 mm BGA / QFN |
| Surface Finish | ENIG |
| Assembly Type | SMT, THT, Mixed Technology |
Our Medical PCB Assembly Services
Explore our full range of medical PCB assembly services, designed to support every stage of your product lifecycle—from prototyping to full-scale production.
Prototype PCB Assembly
Rapid and flexible prototyping solutions designed to accelerate medical device development, testing, and validation.
Ideal for R&D and early-stage product validation
Turnkey PCB Assembly
End-to-end PCB assembly services covering component sourcing, manufacturing, and testing for a streamlined production process.
One-stop solution to reduce complexity and lead time
Low Volume PCB Assembly
Reliable low-volume production with consistent quality, ideal for pilot runs and early-stage medical product launches.
Perfect for bridging prototype to mass production
Medical SMT Assembly
High-precision SMT assembly for fine-pitch and high-density medical PCBs, ensuring accuracy and repeatability.
Supports complex designs with tight tolerances
BGA Assembly
Advanced BGA assembly with X-ray inspection to ensure reliable solder joints for critical medical applications.
Ensuring hidden solder joint integrity and reliability
Our Medical PCB Assembly Process
From engineering review to final delivery, each step is carefully managed under our ISO 13485 quality system to minimize risk and guarantee consistent performance.
DFM & Engineering Review
We conduct detailed Design for Manufacturability (DFM) analysis to identify potential risks, optimize layouts, and ensure efficient and reliable production from the start.
Component Sourcing & Verification
All components are sourced from qualified suppliers and undergo strict verification to ensure authenticity, compliance, and long-term stability.
PCB Fabrication
High-quality PCB fabrication is carried out in accordance with medical-grade standards, ensuring structural integrity and electrical performance.
SMT & THT Assembly
Using advanced SMT lines and controlled processes, we ensure precise placement and consistent soldering quality for complex medical electronics.
In-Process Inspection
Multiple inspection stages, including SPI, AOI, and X-ray, are implemented to detect defects early and maintain high production quality.
Functional Testing & Validation
We perform functional testing to verify electrical performance and ensure that each product meets design specifications and application requirements.
Final Quality Assurance
Before shipment, all products undergo final inspection and quality checks to ensure compliance with IPC Class 3 standards.
Packaging & Delivery
Products are securely packaged with full traceability documentation, ensuring safe delivery and complete transparency.
Why Medical OEMs Choose Sugamed for PCB Assembly
Medical OEMs worldwide choose Sugamed because we combine high-precision process capability with the compliance infrastructure that regulatory approval demands.
Sub-micron inspection
100% X-Ray coverage with <0.1 μm resolution and μCT 3D imaging — detecting voids and cold joints invisible to conventional AOI.
Ultra-fine pitch placement
±0.025 mm IC placement accuracy. BGA down to 0.35 mm pitch, 01005 chip capability — engineered for life-critical device tolerances.
Closed-loop quality chain
SPI → AOI → FAI → X-Ray — every stage generates traceable data. Auto-generated FAI reports ready for regulatory submissions.
Production scale
21 SMT lines across China and Vietnam deliver lot-to-lot consistency from prototype validation through full-volume production.
Complex board capability
Up to 40-layer boards, 800 × 600 mm panel size, mixed-technology and Flex PCBA assembly — one partner for your most demanding designs.
Compliance-aligned QMS
Aligned with ISO 13485 and supporting customers through FDA 21 CFR Part 820 process qualification requirements.
FAQ
Are your assemblies built to IPC Class 3?
Yes. IPC Class 3 is our standard for medical boards — tighter inspection criteria, stricter solder joint requirements, and more detailed in-process checks. It’s not something we switch on for certain customers; it’s just how medical work is done here.
What testing do you run on medical PCBA?
We use SPI, AOI, X-Ray (including μCT for 3D cross-section analysis), and FAI. The exact combination depends on your board complexity — we’ll recommend what actually makes sense rather than running every test by default.
How do you handle component sourcing?
We source through authorized distributors. For any substitutions, we’ll flag them to you first — nothing gets changed without your sign-off, especially on medical builds.
What if there's a quality issue after delivery?
Contact us directly. We’ll pull the batch records, review inspection data, and give you a clear picture of what happened. If it’s on us, we fix it. We don’t make medical customers chase after answers.
Ready to get started on your project?
Whether you’re evaluating us for a new project or transitioning from another supplier — the starting point is a direct conversation with our engineering team.
Discuss Your Project
Share your board complexity, volumes, and regulatory requirements. We'll give you a clear picture of what we can do and what the timeline looks like.
Schedule a Facility Visit
On-site visits to our Dongguan facility can be arranged — production floor access, quality system review, and time with engineering team leads.