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.
Where a medical board stops being a component
The same board, built to the same drawing, behaves differently once it enters a device submission. What separates the two cases is not the layer count or the substrate but where the acceptance criteria come from, and how long they have to keep holding.
- Who defines acceptance. On an industrial order the customer drawing defines what passes; on a device the drawing is one input, and the criteria are fixed by the device validation before the board is purchased. The question that belongs in the quotation is therefore how each criterion will be measured, not only whether the process can reach it.
- Where a change lands. An industrial revision lands on the next build. On a device it lands on a submission that already exists, so a change carries an assessment with it, which is why confirmation comes before the work rather than after it.
- Whether the proof repeats. A passing lot proves an industrial order. A device has to show the same process again at the next lot and years later in an audit, so the process is held as fixed parameters rather than as the skill of whoever happened to run it.
The line is drawn on the submission, not on the price of the equipment. Drawn in the wrong place, the process still looks correct — what is missing only surfaces when the design history file is opened.
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.
A recent programme
A 2025 build for a German EMS company shows how these points meet on one board: an 8-layer, 2+N+2 HDI remote medical sensing controller with BGA packages and an ENIG finish, running at 0.06 mm line and space. The board was sourced, assembled and tested as one order, the BGA joints were checked by X-ray, AOI and a functional test, and the samples shipped in 10 days against a date written into the agreement. The case study sets out the DFM review and the soldering controls behind it.
What a medical quotation is actually pricing
A medical quotation and an industrial one for the same Gerber set rarely differ by board area. They differ by how much of the device acceptance has been turned into a measurable step, and that work is priced alongside the fabrication.
- Translating device acceptance into lineside checks. First-article work, micro-sections and coupons that show the board itself meets what the device file claims, plus an inspection sequence agreed before the first lot instead of chosen at the machine.
- The record and its release. One lot record covering fabrication and assembly, with the images and test data behind it, issued with the goods; the sequence it documents is described in PCBA testing and quality assurance.
- Re-confirmation after a change. A revision returns to the confirmed state, is re-run and re-recorded, and the written confirmation that goes back to the device side is part of the work rather than paperwork around it.
Price and evidence move together here as well. An order that carries less of the second is not cheaper in total — it hands the missing part to the device programme, where it has to be rebuilt under audit pressure instead of being issued as the goods leave the line.
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.
