ISO 13485 certified. IPC Class 3 capable. Full component traceability. We manufacture PCBs and PCBAs for medical devices to the quality standards your regulatory submissions require.
From diagnostic equipment to wearable health monitors — we manufacture PCBs and PCBAs for the full range of medical device categories.
A failed solder joint in a consumer product is a warranty claim. A failed solder joint in a ventilator or infusion pump is a patient safety event. The manufacturing discipline required for medical electronics is categorically different — and ISO 13485 is how we prove it.
Every component lot, every solder paste batch, every reflow profile, and every inspection result is recorded and traceable to the individual board serial number. DHR (Device History Record) documentation available on request.
IPC-A-610 Class 3 assembly and inspection for life-sustaining and critical medical devices. 100% AOI, 100% X-Ray on all BGA packages, and ICT or flying probe electrical test on every board before shipment.
Post-assembly ionic contamination testing (ROSE test) available for medical assemblies requiring cleanliness verification. Conformal coating, underfill, and potting available for moisture and contamination protection.
Our ISO 13485 quality system generates the manufacturing documentation your FDA 510(k), CE marking, or MDR technical file requires. Material declarations, process records, and inspection reports provided with every order.
PCB Fabrication
| Parameter | Specification |
|---|---|
| Layer Count | 1 to 32 layers; HDI available |
| Material | FR4, High-Tg FR4, Rogers, Flex PI, Rigid-Flex |
| Min Trace / Space | 3/3 mil standard; 2/2 mil HDI |
| Min Hole Size | 0.1 mm laser (microvia); 0.2 mm mechanical |
| Board Thickness | 0.4 mm to 6.0 mm |
| Surface Finish | ENIG, OSP, ENEPIG, Immersion Ag/Sn |
| Impedance Control | +/-5% standard; +/-3% precision |
| Prototype Lead Time | 24 hours |
PCBA Assembly
| Parameter | Specification |
|---|---|
| Assembly Type | SMT, through-hole, mixed, flex assembly |
| Min Component | 01005 imperial; 0201 metric |
| Min BGA Pitch | 0.4 mm; CSP and LGA supported |
| Placement Accuracy | +/-0.025 mm (Cpk ≥ 1.67) |
| Solder | Lead-free SAC305; leaded SnPb available |
| Reflow | 8-zone nitrogen atmosphere oven |
| Inspection | SPI, AOI, 2D/3D X-Ray, ICT, flying probe |
| Quality Standard | IPC-A-610 Class 2 / Class 3; ISO 13485 |
Email: all@poe-pcba.com
Whatsapp: 85292069596
Tel: 0755-25312250/ +8613798543496
Factory Address: Floor 3, Jinyuan Industrial Park, No. 56, Tangtou Avenue, Shiyan Town, Baoan District, Shenzhen China
