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Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing

Categories One Stop PCBA
Supply Ability: 50,000 PCS
Model Number: QHPCBA-MED-0808
Delivery Time: 8 Hours
Min Component Size: 0201 (0.6mm × 0.3mm)
Place of Origin: Shenzhen, China
Price: $25
Packaging Details: Anti-static + vacuum packaging + cardboard box
Quality Standard: IPC-A-610 Class 3
Documentation: Complete Device History Record
MOQ: 1
Inspection: 100% AOI + X-Ray + Functional Test
Certification: ISO 13485, IATF 16949, ISO 9001, IPC Class 3, UL, RoHS, REACH
Brand Name: QHPCBA
Payment Terms: Western Union, T/T
Traceability: Component Lot to Final Test Report
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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

RequirementQHPCBA Standard
CertificationISO 13485 Medical Devices QMS
WorkmanshipIPC-A-610 Class 3 (Zero-Defect Target)
TraceabilityComponent Lot → Assembly → Test → Ship
Inspection100% AOI + X-Ray (BGA/QFN) + Functional Test
DocumentationComplete DHR with test reports per batch
CleanlinessNo-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.

Quality Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing for sale
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