Medical PCB Manufacturing
FDA 510(k)-ready PCBs — built in an ISO 13485 shop.
Medical-grade PCB fabrication with full DHF / DHR traceability. We support FDA 510(k), CE MDR and Health Canada submissions — documentation package ships with every build lot.
- 13485 audited
- ISO
- Ready
- 510(k)
- MDR 2017/745
- CE
- Traceable
- 100%
Device Classes We Build For
From diagnostic to implantable
Different risk classes need different processes. Below is what we support and the regulatory path for each.
Medical Applications
Where medical PCBs ship
Medical PCB Capability
Published medical-grade spec
| Quality system | |
| Certification | ISO 13485:2016 (SGS audited) |
|---|---|
| Risk management | ISO 14971 |
| Regulatory support | FDA 510(k) · CE MDR 2017/745 · Health Canada |
| Documentation | |
| DHF (Design History File) | Provided · revision-controlled |
| DHR (Device History Record) | Per lot · 15-year retention |
| Traceability | Serialized · raw laminate → finished board |
| Board capability | |
| Layer count | 1 – 20 layers |
| Materials | FR-4 · Rogers · Flex (Pyralux) · Aluminum |
| Min trace / space | 3 mil / 3 mil |
| Testing | |
| Inspection | 100% AOI + X-ray + flying probe |
| Sterilization compat | EtO · Gamma · Autoclave (material-dependent) |
| Biocompatibility | USP Class VI · ISO 10993 (when specified) |
Frequently Asked Questions
Medical PCB FAQ
01What does "FDA 510(k) ready" actually mean?
Our documentation package includes everything your regulatory affairs team needs: DHF, DHR, material COC, process validation, biocompat summary. It doesn’t replace your submission — it means we supply the PCB-side evidence.
02Can you support Class III implantable PCBs?
Yes — but we’ll need a design review upfront. Class III adds full biocompat testing (ISO 10993), sterilization validation, and shelf-life accelerated aging. We partner with your team from the start.
03How long do you retain DHR records?
Minimum 15 years post shipment — longer on request. All records are digitally archived with access-controlled retrieval.
04Can we audit your facility?
Yes. We host customer audits (QSIT and supplier quality) quarterly. Full access to shop floor, DHR system and material traceability.
Ready when you are
Send your Gerber & BOM — get a quote in 24 hours.
NDA available · Free DFM review · Senior engineer response.