Kingdta manufactures medical-grade PCBAs for diagnostic equipment, patient monitoring systems, therapeutic devices, and medical imaging applications. Our quality management system is aligned with ISO 13485 medical device quality requirements, providing the traceability, process control, and documentation that medical device manufacturers require.
Medical PCBA: Quality & Compliance
Medical device electronics must meet the highest reliability standards of any industry. A failure in a patient monitoring system, infusion pump, or diagnostic device can directly impact patient safety. This demands zero-defect assembly quality, complete component traceability, and rigorous process control throughout manufacturing.
ISO 13485 quality management for medical device manufacturing requires documented procedures for every process step, calibrated test equipment, controlled component storage, and complete records retention. Kingdta's quality management system maintains records for a minimum of 10 years, supporting post-market surveillance and regulatory audit requirements.
Component traceability in medical PCBA requires recording the manufacturer, lot number, and date code of every component used in each assembly. Our MES system captures this information automatically during production, generating a complete component history for every board that can be retrieved years after production.
Technical Specifications
Key Advantages
ISO 13485-Aligned Quality System
Quality management processes aligned with ISO 13485 medical device requirements, supporting regulatory submissions.
Full Component Traceability
MES system records component manufacturer, lot number, and date code for every component on every board.
10-Year Record Retention
Complete production and test records retained for 10 years to support post-market surveillance and audits.
IPC-A-610 Class 3 Inspection
Highest workmanship standard for safety-critical medical device assemblies.
Ionic Contamination Testing
Cleanliness testing per IPC-7711/7721 to verify PCB cleanliness for implantable and high-reliability applications.
Device History Records
Complete DHR (Device History Record) documentation per 21 CFR Part 820 requirements.
Where It's Used
Patient Monitoring
ECG monitors, pulse oximeters, vital signs
Diagnostic Imaging
Ultrasound, X-ray, MRI electronics
Therapeutic Devices
Infusion pumps, ventilators, TENS units
Surgical Equipment
Electrosurgical units, surgical robots
Laboratory
Analyzers, centrifuges, PCR machines
Dental
Imaging systems, treatment units
Wearable Medical
CGM sensors, cardiac monitors
Implantables
Neurostimulators, cochlear implants
Why Choose Kingdta for Medical PCBA?
- ISO 13485-aligned quality management system with documented procedures for all process steps
- Full component lot traceability via MES system — every component recorded for every board
- 10-year record retention for post-market surveillance and regulatory audit support
- IPC-A-610 Class 3 inspection for safety-critical medical device assemblies
- Ionic contamination testing and biocompatible material options for implantable applications
- Device History Record (DHR) documentation support for FDA 21 CFR Part 820 compliance
Frequently Asked Questions
Are you ISO 13485 certified?
We are ISO 9001:2015 certified with quality management processes aligned with ISO 13485 requirements. We maintain full component traceability, documented procedures, and 10-year record retention. We are working toward full ISO 13485 certification and can provide a quality system overview for your supplier qualification process.
Can you provide Device History Records (DHR)?
Yes. We generate Device History Records for medical device orders, including component traceability records, process parameter records, inspection results, and test reports for each assembly. DHR documentation is provided in formats compatible with FDA 21 CFR Part 820 requirements.
Do you offer burn-in testing for medical PCBAs?
Yes. We offer burn-in testing at elevated temperature (typically 50–70°C) for specified duration to screen for early-life failures. Burn-in test parameters are configured per your specification.