Medical Electronics PCB
The group's Ji'an production base holds ISO 13485:2016 medical device quality management certification, delivering IPC Class 3 PCB manufacturing with fully traceable process control.
ISO 13485:2016 Medical Device Quality Management System
- Certificate number
- 134947
- Certificate holder
- SunKing Ji An Circuits Electronics Co., Ltd. (Ji'an production base)
- Registered scope
- Manufacturing of circuit boards for medical devices (ventilators). Held by the group's Ji'an production base, where medical projects can be scheduled.
- Certification body
- NQA (UKAS 0015 / IAF MLA)
- Validity
- 2025-04-17 — 2028-04-17
The certificate is held by the group's Ji'an production base, and coverage follows the registered scope as printed. Medical categories beyond ventilators are likewise organized to ISO 13485 requirements, with the specific quality plan confirmed in writing. Certificate details can be verified via CNCA (www.cnca.gov.cn) and SNQA (www.snqa.com.cn).
View the certificate (PDF)
Process controls for medical PCBs
IPC Class 3 manufacturing
Accepted to IPC-6012 / IPC-A-600 Class 3, with hole-wall copper, pad peel strength and layer-to-layer registration controlled to Class 3 requirements.
High-Tg and specialty substrates
High-Tg FR-4, halogen-free laminates and polymer materials to support sterilization tolerance and long-term reliability.
ENIG / ENEPIG finishes
Finish options for fine-pitch components and gold-wire bonding, selected against solderability and contact-reliability needs.
Precision impedance control
Standard impedance tolerance ±10%, with ±5% available for advanced requirements (stack-up and test plan subject to engineering review).
100% electrical test
Flying-probe or fixture testing on every order, with microsection analysis and ionic cleanliness testing to verify process stability.
End-to-end traceability
The Ji'an base runs ERP and MES intelligent traceability, covering records from raw-material lot through to finished board.
Frequently asked questions
Do you hold medical device certification?
Yes. The group's Ji'an production base (SunKing Ji An Circuits Electronics Co., Ltd.) holds ISO 13485:2016 medical device quality management certification, certificate number 134947, issued by NQA under UKAS accreditation 0015, initially certified 17 April 2025 and valid until 17 April 2028. The registered scope is the manufacturing of circuit boards for medical devices (ventilators), and medical projects can be scheduled at that base.
Can you handle medical projects outside the ventilator scope?
Yes. To be precise: the registered scope of the ISO 13485 certificate is circuit boards for ventilators, so other medical categories are not within the certificate's literal coverage. Such projects are still organized to ISO 13485 requirements for design review, process validation and traceability, with the specific quality plan confirmed in writing. Please state the end-device type and applicable regulatory requirements when requesting a quote.
Which base will produce my medical order?
The ISO 13485 certificate is held by the Ji'an production base, so medical orders that must run under that certified system are scheduled there. The group also operates the Huizhou base, certified to ISO 9001, ISO 14001 and IATF 16949, serving telecom and automotive electronics. Please confirm before ordering whether production under the ISO 13485 system is required so scheduling can be arranged.
What quality documentation can you provide for medical projects?
Standard deliverables include a certificate of conformance (COC), material certifications and lot records, impedance test reports, microsection analysis reports, electrical test records, and RoHS/REACH compliance statements, with traceability data and process parameter records available on request. First article inspection (FAI), process validation support (IQ/OQ/PQ) and audit support are agreed separately at project kickoff, per the quality plan confirmed in writing.
Have a medical PCB project to assess?
When requesting a quote, tell us the end-device type, applicable regulations, and whether production under the ISO 13485 system is required.