A board in a medical device is approved as part of that device. Years after the submission is filed, an auditor or a notified body can ask how a specific lot was built, and the answer has to exist. That is what ISO 13485:2016 adds to an ordinary PCB order: not a different copper weight, but a different standard of evidence.
What medical boards have to survive
Imaging and diagnostic instruments run continuously in a sealed enclosure; monitoring hardware is carried, dropped and cleaned; a wearable has to bend without breaking a trace; a sterilisation or power section can run hotter than FR-4 accepts. The substrate and finish follow that duty rather than a house default, which is why the choice is made with engineering at the stack-up stage. The published limits sit on the capability page and apply to every industry.
The lot record is the product
Fabrication and assembly share one plant, so one record follows the build from bare board to assembled unit: the stack-up, the material batch, the inspection results and the test data, without a supplier handover in the middle where responsibility changes hands. When a device submission or an internal audit asks how a board was produced, that record is the answer.
The inspection sequence behind it is the same one used for production: SPI before placement, AOI on both sides after reflow, X-ray where joints are hidden, first-article inspection against the CAD data and 100 % electrical test before packing. It is described in full on quality assurance.
Small lots without a separate process
Device development rarely starts at volume. A pilot lot of one to fifty boards runs on the production lines with the production inspection, so the board that is tested clinically is built the way the production board will be built. Once the design is frozen, the same stack-up and placement programme carry into volume, and the volume price is quoted from the data package rather than from a list.
Changes, confidentiality and visits
A change to the stack-up, finish or placement programme is quoted and confirmed in writing before it runs, and an unavailable component is replaced only after the alternative is approved. Drawings that cannot be shared openly can travel under a mutual NDA from the first exchange, and a visit to the Shenzhen or Meizhou plant can be arranged around the processes the device would use — including a look at the inspection stations that produce the lot record.
Next step
Send the Gerber set, the BOM and pick-and-place file if assembly is included, the quantity and the target date; a complete package is quoted within 24 to 48 hours. Board families used in device work have their own pages — flex and rigid-flex, HDI and ceramic — and turnkey assembly covers the build after the board. The certificates are on the certifications page, the rest of the industries we serve are on the industries page, and a quote can be requested on the contact page.
