医疗器械 - ISO 13485认证

医疗电子的PCB与PCBA

ISO 13485 Certified Manufacturing

ISO 13485意味着医疗器械电子产品的受控流程、文件化检验和可追溯性。

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.