Med-grade assembly without the friction.
ISO 13485-ready electronics manufacturing for medical devices — IPC Class 3 boards, DHR-ready lot records and 100% tested devices, built in Shenzhen's Bao'an plant and shipped with documentation your auditor can read — traceable from component to device, and from device to shipment.
Med-grade assembly without the friction.
Regulated hardware lives or dies on evidence. Our medical builds combine ISO 13485-ready process alignment with the speed of an integrated electronics plant: IPC Class 3 workmanship, per-lot DHR-ready records, 100% electrical test and traceability. Your RA team gets audit-ready files instead of four vendors each promising their own version of the truth — and pilot runs start at 1-100 pieces while the design is still moving. Firmware-bearing and Class II devices get the same answer: a supply agreement with a documented spine, not a supply shuffle. The audit does not surprise us; it visits us.
How we run quality gates
Evidence, not promises.
Eight elements of a medical build, with the record to back each one — and a ninth, change control, for when the design moves.
| Medical program element | How we run it |
|---|---|
| Quality system | ISO 13485-ready process alignment across the network, with ISO 9001:2015 and ISO 14001:2015 certified at the Bao'an campus. Audit checklists welcome. |
| Workmanship | IPC Class 3 assembly from prototype panels to 58-layer HDI designs, with automated optical inspection on every placement line. |
| Lot documentation | DHR-ready device history records: components, placement programs, test results and rework logs, archived per lot and indexed for audit retrieval. |
| Traceability | 100% electrical test before shipment with per-unit results mapped to the lot — the record your field investigation needs, and the one a recall would live or die on. |
| Pilot manufacturing | Validation and pilot builds from 1-100 pieces, DFM-reviewed before the first board, so evidence is generated while design changes are cheap. |
| Materials declarations | RoHS and REACH data shipped with the BOM file set, per-part, per-vendor, ready to fold into your technical file — declared once, not rediscovered at the border. |
| Export documentation | CE, FCC and UKCA file packages plus RoHS declarations aligned with the device's target markets, prepared by the same desk that builds — and tracked per destination country so nothing arrives at the border without its folder. |
| Change control | Engineering change notices logged against the lot record, incoming component change notifications reviewed by the same engineer, and your RA team kept inside the approval loop. |
| Program cadence | Engineering quotes within 24-48 hours and one accountable project owner from pilot through volume production — the person who answers change questions is the person who built the pilot. |
Your device, defensible from day one.
What ships with every medical electronics lot we build — the same evidence set for a 50-piece pilot and a 5,000-piece run.
Build it like your auditor is watching.
Send the design, the BOM, or the audit checklist itself. The engineering desk returns a DFM review, a documentation map and a fixed quote within 24-48 hours — from Shenzhen, with records. Evidence by default, arguments by appointment.
Request a quote See project formats