Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing
Medical Device PCBA Assembly — ISO 13485 Certified
QHPCBA provides ISO 13485 certified medical device PCBA assembly with complete traceability from component lot number to final test report. Every medical PCBA ships with a full Device History Record (DHR) for regulatory compliance.
Medical-Grade Quality Requirements
| Requirement | QHPCBA Standard |
|---|---|
| Certification | ISO 13485 Medical Devices QMS |
| Workmanship | IPC-A-610 Class 3 (Zero-Defect Target) |
| Traceability | Component Lot → Assembly → Test → Ship |
| Inspection | 100% AOI + X-Ray (BGA/QFN) + Functional Test |
| Documentation | Complete DHR with test reports per batch |
| Cleanliness | No-clean flux process, ionic contamination tested |
Medical Applications We Support
- Patient monitoring systems
- Diagnostic imaging equipment
- Implantable device controllers
- Surgical instrument electronics
- Wearable health monitors
- In-vitro diagnostic (IVD) devices
Why QHPCBA for Medical PCBA
In-house stencil, CNC fixture, and SMT assembly under one ISO 13485 certified roof. No subcontracting means your design stays within a controlled quality system from start to finish. Engineering team reviews every design for medical-specific requirements including creepage distances, isolation barriers, and biocompatible materials.
Contact QHPCBA today for your medical device PCBA project. ISO 13485 certified. Full traceability. IPC Class 3 assembly.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.