1. Medical-Grade Quality Assurance

• Certifications: ISO 13485 (medical), ISO 9001, and UL 60601.
• Inspection Stages:
  • Pre-Production: Material testing for biocompatibility (USP Class VI) and RoHS compliance.
  • In-Process: 3D AOI inspection for solder joint integrity in miniaturized medical components.
  • Final: X-Ray and functional testing for implantable device PCBs.

2. Certified Expertise in Medical, AI, and Industrial PCBA/SMT

• Medical: Specialized in ISO 13485-compliant PCBA for diagnostic equipment and wearables.
• AI: Proficient in high-density interconnect (HDI) PCB assembly for GPU/CPU servers.
• Industrial: Experienced in ruggedized PCBA for IPC Class 3-rated machinery.

3. Advanced Facilities for Precision Processing

• Equipment:
  • Panasonic NPM-W2: 50,000 CPH for high-volume AI hardware.
  • DEK Horizon 03iX: ±25μm accuracy for 0.3mm pitch components.
  • Yamaha YSi: Vision-guided placement for flexible PCBs.
• Testing:
  • Thermal Cycling: -40°C to 125°C for EV battery management PCBs.
  • ESD Protection: ANSI/ESD S20.20 compliance for medical device assembly.

4. Customized Solutions for Diverse Applications

• Medical:
  • Low-Volume Prototyping: 3–5 days for wearable medical device PCBs.
  • DFMEA Analysis: Reduces risks in implantable device design.
• AI:
  • HDI PCB Layout: 20-layer designs for edge computing systems.
  • Thermal Management: Liquid-cooled solutions for AI server PCBs.
• Industrial:
  • Ruggedized PCBA: IP67-rated for harsh environment applications.
  • IoT Integration: Embedded connectivity for industrial automation.

5. Efficient Supply Chain & Compliance

• Component Sourcing:
  • Authorized Distributors: Avnet, Digikey for authentic components.
  • RoHS/REACH Compliance: Ensures sustainable PCB manufacturing.
• Delivery:
  • Global Logistics: DHL/FEDEX partnerships for USA/Europe shipments.
  • Lead Times: 7–14 days for high-mix, low-volume PCBA.

• Medical Leadership: 100+ successful projects for FDA-approved devices.
• AI Innovation: Partnered with NVIDIA for high-speed PCB assembly.
• Industrial Reliability: 99.9% on-time delivery for IPC Class 3 PCBs.

Request a Quote for ISO 13485-Certified PCBA

Contact us for turnkey SMT processing, custom PCB design, or quick-turn prototyping. Let’s build your next generation of electronics with precision and compliance.