ISO 13485 certified printed circuit boards engineered for life-critical medical applications. From implantable devices to diagnostic imaging, our medical-grade PCBs meet the highest biocompatibility and reliability standards.
Four specialized PCB solutions designed for critical healthcare applications, each manufactured under strict medical-grade quality protocols.
Ultra-miniaturized, hermetically sealed PCBs for pacemakers, neurostimulators, and implantable drug pumps requiring absolute long-term reliability.
| Layer Count | 4–8 Layers |
| Material | High Tg FR-4 / Polyimide |
| Board Thickness | 0.2mm – 0.8mm |
| Trace/Space | 2mil / 2mil |
| Surface Finish | ENEPIG / Immersion Gold |
| Biocompatibility | ISO 10993-5 / -10 |
| Operating Temp | +35°C ~ +42°C (Body) |
| Certification | ISO 13485 / FDA Class III |
High-precision analog-digital mixed-signal PCBs for patient monitors, ECG machines, and vital signs acquisition with ultra-low noise design.
| Layer Count | 6–14 Layers |
| Material | High Tg FR-4 / Rogers 4350B |
| Trace/Space | 3mil / 3mil |
| Impedance Control | ±5% Tolerance |
| Surface Finish | ENIG (5μ" Au) |
| Signal Integrity | <1pA Leakage Current |
| Operating Temp | +10°C ~ +40°C |
| Certification | ISO 13485 / IEC 60601-1 |
Ultra-compact HDI PCBs for endoscope camera heads and medical imaging systems, delivering high-resolution video in minimally invasive procedures.
| Layer Count | 6–10 Layers HDI |
| Material | Low Dk / Low Df FR-4 |
| Board Size | 5mm × 5mm – 20mm × 20mm |
| Min Via | 0.075mm Laser Microvia |
| Surface Finish | ENIG / ENEPIG |
| Signal Speed | Up to 12Gbps |
| Operating Temp | +10°C ~ +50°C |
| Certification | ISO 13485 / FDA Class II |
Bendable polyimide-based PCBs for catheter-based devices, wearable monitors, and surgical instruments requiring dynamic flexing during use.
| Type | Flex / Rigid-Flex |
| Material | Polyimide (Kapton) |
| Layer Count | 1–6 Layers |
| Min Bend Radius | 3× Board Thickness |
| Copper Weight | 1/2oz – 2oz |
| Surface Finish | Immersion Gold / OSP |
| Flex Cycles | ≥100,000 Cycles |
| Certification | ISO 13485 / IPC-6013 |
ISO 10993 certified materials
<1pA leakage current design
DHF & DMR documentation
Electrical + functional + AOI
Our medical engineering team understands the unique requirements of ISO 13485 and FDA regulations. Get a tailored quote for your medical device PCB.
Request Medical Quote