Medical Electronics

ISO 13485 precision manufacturing for CT control boards, blood pressure monitors and ear thermometers.

ISO 9001ISO 13485IATF 16949GJB Military

Capability match

Medical devices demand traceability over throughput. Our records cover material lots, process parameters and test data, archived per work order.

High-density board process

Traceability completeness

Low-volume flexibility

Scale cost advantage

Ratings reflect current line configuration and system coverage

Boards & key process

PCBA

Medical control board

X-RAY

BGA joint X-Ray

Inspection chain before shipment

IQC

Incoming QC Electrical & visual sampling

SPI

Paste inspection 2.5D paste height

FAI

First article Part-by-part verification

AOI

Optical inspection Pre & post reflow scan

X-RAY

Solder X-Ray Hidden BGA joint imaging

ICT/FCT

Electrical & functional In-circuit + functional

OQC

Outgoing QC Dimension & final visual

FAQ

Is Fuyue ISO 13485 certified?

Yes — certified to ISO 13485 (2016) for medical device quality management in 2022.

How is traceability ensured for medical boards?

Material lots, process parameters and test data are archived per work order and retrievable at shipment.

Which medical products have you built?

CT main control boards, blood pressure monitors, ear thermometers and similar control boards.

Line capabilities serving this sector

Have a project in this sector?

Tell us the compliance bar and volume — we will map the process and documentation.