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Add: Room 2314-2315, Zhonghui International Financial Center, Nansha District, Guangzhou.
Medical Equipment PCBA
Process Parameter
Medical Device PCBA – ISO 13485 Certified, Class I/II/III Compliant for Critical Healthcare Applications
Our medical-grade PCBA is engineered to meet the strictest regulatory and performance standards for life-critical and diagnostic healthcare equipment. Built with ISO 13485 certified processes, medical-grade components, and zero-defect quality control, it ensures safe, stable, and long-term operation in hospitals, clinics, and home healthcare settings – ideal for patient monitoring, diagnostic imaging, surgical equipment, and portable medical devices.
Key Features:
✅ ISO 13485 & Regulatory Compliance: Full compliance with global medical device standards (FDA 21 CFR Part 820, EU MDR/IVDR), traceable component sourcing & production records
✅ Ultra-High Reliability: 100% AOI, ICT, X-ray inspection, functional & burn-in testing, ESD protection, and conformal coating for zero-defect quality
✅ Biocompatible & Safe: RoHS & REACH compliant, lead-free assembly, and materials suitable for direct/indirect patient contact
✅ Customizable & Scalable: Support Gerber/BOM customization, 2-20 layer PCBs, rigid-flex, HDI, and high-precision miniaturized designs
✅ One-Stop Medical Solution: PCB fabrication, component sourcing (authorized medical-grade channels), PCBA assembly, testing, sterilization-ready packaging & box build
✅ Fast & Controlled Lead Times: Prototypes in 5-10 days, mass production with consistent quality and regulatory documentation support
Applications: Patient monitors, ECG/EKG machines, ultrasound/imaging equipment, infusion pumps, surgical robotics, diagnostic analyzers, portable medical devices, and home healthcare wearables.
Why Choose LEIZZI?With 15+ years of PCB & PCBA manufacturing experience, we specialize in medical electronics, offering DFM/DFA optimization, regulatory compliance support, and full traceability for every batch. Partner with us for your medical device PCBA projects – safety you can trust, performance you can rely on.
Areas of Application
Consumer Electronics
Aerospace
Telecommunications
Military Defense
Automotive Industry
Industrial Control
Why Choose Us ?
One-stop PCB PCBA service
Advanced equipment and technology
24 hours high quality online service
Fast delivery speed
Accreditation
Packaging & Transportation
Static electricity bag+EV pearl cotton
Anti-static bubble bags + carton slot
Carton slot + bubble foam
Anti-static kraft bubble bags
Shipping Way
For small packages, we advise to choose by express (such as DHL, UPS, FedEx, and EMS by door to door service!)is the quickest way.
For heavy packages, the best solution is by seafreight.
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Lihai Industrial Park, Baohuan Middle Road, Shatian Town, Dongguan , China.
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