Quality Systems Built for Medical Device Supply Chains
Every board we fabricate and assemble operates under documentation, traceability, and process control requirements aligned with FDA 21 CFR Part 820 and ISO 13485:2016. When your supplier qualification audit reaches us, the paperwork is already in order.
- ✦ ISO 13485:2016 Certified
- ✦ FDA Establishment Registered
- ✦ IPC Standards Compliant
Our Current Certifications
The three certifications below carry specific, auditable obligations — for how we run production, how we handle nonconformances, and how we respond when a customer needs to verify our quality standing. Here’s what each one means in practice.
Certification Body: [Suga Electronics (Dongguan)] Certificate Number: [MD 646563] Valid Through: [2028-03-15] Scope: Design support, fabrication, and assembly of printed circuit boards for use in medical devices
ISO 13485 was written specifically for organisations in the medical device supply chain — it’s not a general manufacturing quality standard applied to medical work. Holding it means our quality management system has been audited by an accredited third party against requirements that assume medical production, not just good general practice.
Registration Number: [3043149893] FEI Number: [3043149893] Registration Type: Contract Manufacturer Status: Active — renewed annually
Our registration is publicly verifiable in the FDA FURLS database — the link below opens the query system directly, so you can confirm current status without asking us for anything.
For 510(k) submissions and FDA supplier documentation requests, our registration number and FEI are directly citable. The registration is renewed every year and kept current as an ongoing obligation, not filed once and forgotten.
IPC Standards — Fabrication & Assembly
IPC standards define the workmanship and acceptability criteria that govern how boards are built and verified. The standards we work to:
Fabrication IPC-A-600 — Acceptability of Printed Boards IPC-6012 — Qualification and Performance Specification for Rigid Printed Boards
Assembly IPC-A-610 — Acceptability of Electronic Assemblies J-STD-001 — Requirements for Soldering Electrical and Electronic Assemblies
Inspection Personnel Our inspection team includes IPC-A-610 CIS certified inspectors. On medical assembly orders, inspection decisions are made by certified personnel.
Standard medical production runs to IPC-A-610 Class 2. Class 3 workmanship criteria are available as a project-specific requirement — if your design calls for Class 3 acceptance, specify it at quoting and it gets documented in the production traveller and applied at every inspection stage from there forward.
Inspection & Test Capabilities
The equipment and processes below apply to medical production orders. All test data is retained as part of the production record and can be included in your incoming inspection documentation if needed.
Automated Optical Inspection (AOI)
100% of boards — post-fabrication and post-assembly Bridging, opens, missing components, polarity errors, solder defects
Flying Probe Electrical Test
100% of fabricated boards Network coverage ≥99%; no fixture required for prototype and low-volume orders
X-Ray Inspection
BGA, QFN, blind/buried via structures BGA solder joint void analysis; via fill quality on HDI boards
Solder Paste Inspection (SPI)
100% post-stencil print Volume, area, height, and offset — catches print defects before placement
First Article Inspection (FAI)
Every production batch Full dimensional and workmanship check on first-off unit before batch release
IST Thermal Stress Testing
On request — High-Tg and thermally demanding boards Accelerated thermal cycling; PTH resistance change under stress; results in production documentation
Functional Test (FAT)
Customer fixture and test spec required We support customer-provided fixtures; assistance with test procedure development available
The equipment and processes below apply to medical production orders. All test data is retained as part of the production record and can be included in your incoming inspection documentation if needed.
Supporting Your Supplier Qualification Audit
Supplier qualification audits are a standard part of how medical device OEMs manage their supply chain — not an unusual request. We keep the documentation current so that when an audit comes up, we’re not scrambling to prepare for it.
What we can provide:
☑ Quality Manual and relevant procedures — available for review under NDA ☑ ISO 13485 certificate and FDA Registration documentation ☑ Representative quality record samples from fabrication and assembly production ☑ Completed supplier qualification questionnaires — standard formats or your own template ☑ On-site facility audit support — scheduling available on request ☑ First-article documentation packages for qualification builds
On-site audits
We welcome customer audits at our facility. Production floor access, quality records, and direct time with our quality and engineering teams are available by appointment. If your qualification process requires a visit, contact us to arrange timing — we don't treat facility audits as a significant logistical event. [Schedule a Facility Visit →]
Start Your Supplier Qualification
Please provide details about your project, and our engineering team will evaluate the product’s manufacturability, quality requirements, and potential risks based on your specific application.
- ISO 13485-aligned processes
- FDA-oriented documentation structure
- Full lot traceability & records available
- Engineering support during qualification
Request Qualification Documentation
Please let us know what the requirements are for your qualification review process. We will respond within one business day and provide the relevant documents and next steps.