Medical imaging equipment PCB

Customer requirement

A PCB for medical imaging equipment on high-Tg, low-loss material: typically 6–10 layers, ~600 components, pilot build. Signal fidelity is paramount.

Manufacturing challenge

• Low-loss material and controlled impedance for imaging signals.
• ISO 13485 traceability and documentation are mandatory.
• FCT validates image-path integrity and noise floor.

Solution

Kilandu runs this board through a controlled NPI-to-production flow rather than a one-shot build:

• DFM: footprint, stack-up and test-point review is completed and fed back before any parts are ordered.
• Sourcing: turnkey procurement of the BOM, with qualified alternates managed for long-lead and obsolete parts.
• SMT: high-speed SMT lines with inline SPI, AOI and X-ray on BGA, voiding and hidden joints.
• Assembly: selective DIP for through-hole content and, where needed, conformal coating.
• Test: ICT for net integrity, then FCT for the board-specific functions above.

ISO 13485 process; AOI + X-ray; FCT on image path.

Result

First-article inspection to IPC-A-610 Class 2/3 is completed, a golden sample is retained as the release baseline, and a pilot run is signed off before mass production. Per-batch traceability (lot, AOI/X-ray records and ICT/FCT logs) is kept. Order quantities and the the customer specific acceptance result are confirmed per project.