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

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.

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

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Product Detail
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
Contact Supplier
Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing
Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing
Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing

Shenzhen Jingchengjie Technology Co., Ltd.

Verified Supplier
1 Years
guangdong, shenzhen
Business Type :
Manufacturer, Trading Company
Main Products :
One Stop PCBA, PCB Prototype, SMT Stencil
Total Annual :
>1000000
Employee Number :
>100
Certification Level :
Verified Supplier
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