Core Architecture of PCB for AI Wearable Devices - Miniaturization · Edge Intelligence · Medical Compliance
Relying on the ISO 13485:2025 certified PCB Manufacturing and Assembly system, we specialize in PCB Assembly for AI-powered Wearable Health Devices. We are reshaping the health monitoring experience with miniature rigid-flex PCBs and edge computing modules:
✅ Ultra-thin High-Density Interconnection
8-layer HDI Stacking: Board thickness of 1.6mm (including 2 layers of flexible circuits), supporting 0.15mm micro-via laser drilling (aspect ratio of 12:1)
Biosensor Integration: Multi-modal ECG/PPG/EMG fusion circuits (impedance matching error tested for 500,000 times)
✅ Global Medical Market Access
FDA SaMD Pre-certification: Complies with the 21 CFR Part 820 quality system
EU MDR Annex XVI: Supports direct connection to the EUDAMED database
China NMPA Green Channel: Fast certification scheme for Class II medical devices
🌐 Mass Production Capacity and Cost Optimization
| Technical Module |
Traditional Solution |
Our Solution |
Efficiency Improvement |
| Motion Artifact Elimination Circuit |
Discrete sensors |
Integrated ASIC |
BOM cost reduced by 37% |
| Battery Compartment Design |
15mm diameter |
10mm ultra-thin irregular PCB |
Device volume reduced by 52% |
| Biocompatibility Certification |
Outsourced to labs |
Conducted in our own ISO 17025 lab |
Certification cycle shortened by 8 weeks |
📥 Limited-time Resource Package
→ Download the "2025 White Paper on PCB Design for Wearable Medical Devices" (including AI algorithm transplantation guidelines)
→ Claim the FDA SaMD Compliance Self-check Checklist (covering 21 CFR Part 11 electronic record requirements)
