Project Overview
Turnkey PCBA manufacturing for a confidential medical-device OEM. The build is a control board for medical monitoring and diagnostic equipment, taken from prototype through pilot into repeat production inside Kilandu's ISO 13485-certified management system. The customer is named Confidential OEM because of an existing confidentiality agreement covering the product.
Customer Requirement
- Medical-grade, fully traceable components
- Mixed SMT and through-hole assembly
- ICT and FCT
- Full material and process traceability
- Change control before any substitution
Engineering Challenges
In medical work, traceability is not an optional extra — it is the baseline the customer is buying. Every component lot had to be held to the approved-vendor list and recorded, and a substitution had to be approved and documented before it was made rather than resolved on the line, because in medical work the change itself is usually the risk. Test coverage had to be sufficient to release a board with confidence, and the documentation had to be able to answer an audit that might arrive long after the build shipped.
Manufacturing Solution
Kilandu conducted a DFM review of PCB layout, BOM and assembly files before production. Medical-grade, fully traceable components were sourced under a build-to-print model with no silent substitution, from authorised and franchised channels, and verified again at incoming inspection against the BOM and approved-vendor list. The board was assembled on our SMT lines with in-line SPI and AOI, with X-ray on selected builds; through-hole parts were handled on DIP lines. Electrical testing combined ICT with a customer-approved FCT.
The process ran under Kilandu's ISO 13485:2016 management system — certificate 35825MDQMS0021R0S — supported by ISO 9001:2015 (CN27125Q0392R0S), with IPC-A-610 Class 2/3 acceptance and per-lot records that tie each shipped board back to its material and process data. Reels and trays arriving without a traceable code are not released to the line.
Build and Capability Data
| Parameter | Specification |
|---|---|
| Assembly | Mixed SMT + DIP |
| In-process inspection | SPI + AOI + X-ray |
| Electrical test | ICT + FCT |
| Traceability | Per-lot material and process records, retained for audit |
| Quality system | ISO 13485:2016 — 35825MDQMS0021R0S · ISO 9001:2015 — CN27125Q0392R0S |
| Workmanship | IPC-A-610 Class 2 / Class 3 |
| Change control | Substitution approved and documented before implementation |
| Lead time | Prototype 5–8 working days · volume production 2–5 weeks · repeat order 2–3 weeks |
| Device category, layer count, board size, BOM count, production volume | Available under NDA on request |
Result
All production lots were linked to material and process records, and the customer approved the first article before repeat production was released. Repeat orders ran to the same approved BOM, process parameters and test limits, and the per-lot records needed for a later audit could still be produced for a build that finished months earlier.
What This Demonstrates
Medical PCBA · ISO 13485 (certificate 35825MDQMS0021R0S) · full material and process traceability · ICT + FCT.
Which ISO 13485 certificate covers this medical work?
Certificate 35825MDQMS0021R0S, issued by Guangdong ZQ Certification Service under CNAS C271-M and valid to 29 June 2028. It is published with the issuing body and validity date on the quality assurance page.
What does full traceability mean on a medical build?
Every component lot is held to the approved-vendor list and recorded, material and process records are captured per lot, and a shipped board can be traced back to its material and process data. Reels and trays arriving without a traceable code are not released to the line.
What happens when a component has to be changed?
A substitution is approved and documented before it is made. In medical work the change itself is usually the risk, so it is not resolved on the line after the fact.