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

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

Name: Medical Device PCBA Assembly Service ISO 13485 Certified with Full Traceability Including Testing
Brand: QHPCBA
Price: 25 USD

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

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 — 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.

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