ISO 13485 PCBA
PCB assembly fully compliant with ISO 13485 medical device quality management standards, ensuring biocompatibility, traceability, and rigorous process controls required for regulated medical applications.
Medical device electronics demand zero tolerance for failure. SFX PCB delivers ISO 13485-certified turnkey PCB fabrication and PCBA small-batch services—from prototype through production-ready builds—with rigorous IPC-A-610 Class 2/3 inspection, biocompatible coatings, and full traceability. Whether you're developing a diagnostic tool, wearable monitor, or drug delivery system, we ensure every board meets the exact standards your device requires.
Comprehensive PCB fabrication and assembly solutions engineered to meet the strict quality and compliance demands of medical device manufacturing.
PCB assembly fully compliant with ISO 13485 medical device quality management standards, ensuring biocompatibility, traceability, and rigorous process controls required for regulated medical applications.
End-to-end turnkey service covering component sourcing, SMT and THT assembly, programming, functional testing, and final inspection—delivering production-ready medical boards with a single trusted partner.
Rapid small-batch prototype assembly for medical device design verification, supporting fast iteration cycles with same-day quotes, flexible BOM sourcing, and professional IPC-A-610-compliant build quality.
Flexible small-to-medium production runs ideal for medical device startups and OEMs, combining strict quality controls with competitive pricing and no oversized minimum order commitments.
Comprehensive in-circuit and functional testing including custom test jigs, AOI, X-Ray inspection, and electrical verification to confirm every medical board meets your exact performance specifications.
Advanced Parylene nano-vacuum coating delivering IPX-8 waterproofing, biocompatibility, and protection against moisture, chemicals, and salt fog—critical for implantable and wearable medical device applications.
Our engineers perform a free, thorough Design for Manufacturability (DFM) and Design for Assembly (DFA) review of your Gerber files and BOM, catching footprint mismatches, trace issues, and medical compliance gaps before a single board is built.
See how medical device engineers and OEMs worldwide rely on SFX PCB to bring life-critical electronics to market.
When patient safety depends on your electronics, partner with a manufacturer whose quality systems, certifications, and experience are built for the demands of the medical industry.
Our ISO 13485-certified facilities meet the exacting quality management requirements of medical device manufacturing, ensuring full regulatory traceability and documentation.
We assemble and inspect to IPC-A-610 Class 2 and Class 3 standards, providing the highest level of solder quality and workmanship required for high-reliability medical electronics.
From a 5-board prototype to full-scale production runs, SFX PCB scales seamlessly without you changing suppliers—protecting design continuity and regulatory documentation integrity.
With manufacturing in Shenzhen and a US office in Plano, Texas, we serve medical device clients worldwide with transparent, direct manufacturer pricing and no middleman markups.
A trusted electronics manufacturing partner for medical device innovators worldwide.
For over 15 years, FX PCB has evolved from a specialist PCB manufacturer into a comprehensive electronics manufacturing partner trusted by medical device companies, healthcare technology startups, and multinational OEMs across the globe. Our dedicated facilities in Shenzhen—home to one of the world's most advanced electronics manufacturing ecosystems—are backed by an ISO 9001, ISO 14001, and ISO 13485-certified quality management system. We've invested continuously in precision SMT equipment, AOI and X-Ray inspection systems, and a skilled engineering workforce committed to zero-defect medical builds. Our US office in Plano, Texas, ensures North American medical clients receive responsive, local support throughout every project. We don't just build boards—we serve as the manufacturing backbone for devices that improve and save lives.
Yes. SFX PCB holds ISO 13485 certification, the internationally recognized quality management standard for medical device manufacturing. Our assembly processes include full material traceability, documented process controls, and quality records required to support FDA, CE, and other regulatory submissions for your medical device.
Talk to our engineering team for a free consultation and project review.
SFX PCB serves medical device manufacturers and engineers worldwide, with manufacturing in Shenzhen and support offices in the United States.
Worldwide
Service Coverage
Plano, TX
US Support Office
2 Factories
Manufacturing Facilities
We ship production-ready medical PCBs to clients worldwide. Contact us to discuss your project.
Medical device quality management system certification
Highest workmanship standard for electronic assemblies
Global market compliance for hazardous substance restrictions
Share your Gerber files, BOM, and project requirements. Our engineering team will provide a detailed quote and free DFM analysis within 1–2 business days—no obligation, no middleman.
For immediate assistance, feel free to give us a direct call at (+1) 5103455000 You can also send us a quick email at info@sfxpcb.com
For immediate assistance, feel free to give us a direct call at (+1) 5103455000 You can also send us a quick email at info@sfxpcb.com