1. ISO 13485-Compliant Order Processing & Project Management

• Medical Projects:
  • Detailed requirement analysis for implantable device PCBs.
  • Compliance with UL 60601 and FDA guidelines.
• AI/High-Tech:
  • DFMEA analysis for high-speed PCB assembly.
  • Rapid quoting for HDI PCB prototypes (3–5 days).

2. RoHS-Compliant Material Sourcing & Traceability

• Components:
  • Authorized distributors (e.g., Avnet, Digikey) for authentic parts.
  • Biocompatible materials (USP Class VI) for medical PCBA.
• PCB Substrates:
  • FR4 (standard), Rogers (high-frequency), and ceramic (high-temperature) for ruggedized industrial PCBs.

3. Advanced Production Processes

A. SMT Assembly

• Equipment:
  • Panasonic NPM-W2 (50,000 CPH) for AI server PCBA.
  • DEK Horizon 03iX (±25μm accuracy) for 0.3mm pitch components.
• Process:
  • Reflow Soldering: Nitrogen-protected for lead-free solder joints.
  • 3D AOI Inspection: 100% detection of solder bridges in edge computing PCBs.

B. Through-Hole & Manual Soldering

• Heavy-Duty Industrial PCBs:
  • Wave soldering for motor control boards.
  • IPC Class 3 manual soldering for complex connectors.

C. Post-Assembly Treatments

• Medical Devices:
  • Biocompatible conformal coating for wearable PCBs.
  • Sterilization compatibility testing.
• Industrial:
  • IP67-rated three-proof paint for harsh environment applications.

4. Stringent Quality Control Framework

• Certifications: ISO 13485, IPC-A-610 Class 3, and RoHS.
• Testing:
  • X-Ray Inspection: Detect hidden defects in BGA chips.
  • Thermal Cycling: -40°C to 125°C for EV battery management PCBs.
  • Functional Testing: Validates performance for medical diagnostic equipment.

5. Automated Equipment & Predictive Maintenance

• Key Machines:
  • Yamaha YSi for vision-guided placement of flexible PCBs.
  • Agilent 3070 for in-circuit testing.
• Maintenance:
  • AI-powered predictive analytics to reduce downtime.
  • ISO 13485 equipment logs for audit trails.

6. Skilled Workforce & Compliance Training

• Team Composition:
  • 150+ engineers and technicians with HDI PCB design expertise.
  • IPC-Certified trainers for SMT assembly and medical device standards.
• Process Adherence:
  • SPC monitoring for critical parameters (e.g., solder paste volume).

7. Sustainable & Safe Operations

• Eco-Friendly Practices:
  • Lead-free soldering and 95% recycling rate.
  • Energy-efficient equipment for low-carbon production.
• Safety:
  • ANSI/ESD S20.20 compliance for medical device assembly.
  • ISO 45001 safety management system.

8. Global Delivery & After-Sales Support

• Logistics:
  • DHL/FEDEX partnerships for 7–14 day delivery to USA/Europe.
  • FDA/CE-compliant packaging for medical products.
• After-Sales:
  • 24/7 technical support for high-reliability PCBA.
  • Product lifecycle management for long-term partnerships.

• 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