Medical Devices - ISO 13485 Certified

PCB & PCBA for Medical Electronics

ISO 13485 Certified Manufacturing

ISO 13485 means controlled processes, documented inspections, and traceability for medical-device electronics.

Medical Devices Quality Management

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All manufacturing steps follow documented procedures per ISO 13485 requirements.

Complete lot traceability, inspection records, and material documentation.

SPI, AOI, X-Ray inspection for invisible defects and solder quality.

0402, 0201, BGA, QFN fine-pitch components

SPI, in-line AOI, X-Ray for critical components

Incoming quality control for all components

Inspection reports, material certificates

PCB design files and bill of materials

For accurate and efficient assembly

Can you support ISO 13485 documentation requirements?: Yes, we can provide inspection reports, material certificates, and traceability documentation as required.
Do you provide inspection reports (AOI/X-Ray)?: Yes, we provide SPI, AOI, and X-Ray inspection reports for medical device assemblies.
How do you ensure component authenticity?: We source components only from authorized distributors and original manufacturers. All components undergo IQC inspection.