Wire Harnesses & Cable Assembly Manufacturer Services
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13485:2016
Managed
Audits
Ready
ISO 13485 Elements
Key medical device quality system elements we implement
ISO 13485:2016
| Standard | ISO 13485:2016 |
| Scope | Medical device wire harness and cable |
| Risk Management | ISO 14971 integrated |
| Clean room | Controlled environment available |
| Traceability | Lot and serial number tracking |
| Validation | IQ, OQ, PQ protocols |
Yuzhan’s ISO 13485-certified quality system delivers medical wire harnesses and cable assemblies you can rely on. Built on ISO 14971 risk management and aligned with FDA requirements, we ensure safety and reliability for your critical medical device applications.
Every medical cable we develop undergoes strict design control and validation – so you can trust its performance in critical applications. Full traceability is embedded in our device history records (DHR), tracking each component from raw material to final assembly. And to protect patients, we perform hi-pot testing for electrical safety, plus environmental stress testing to verify long-term reliability.
Process validation using IQ, OQ, PQ protocols ensures manufacturing processes produce consistent results. Crimping and soldering processes are validated per medical device requirements. Controlled environment assembly available for sensitive applications. IPC/WHMA-A-620 workmanship standards apply.
Our ISO 13485 certification aligns with FDA 21 CFR Part 820 Quality System Regulation, supporting your FDA submission and compliance efforts. Customer-specified UL standard support can be included where a medical cable program requires UL material, label, or test documentation. Quality systems ensure consistent medical cable production.
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100% real on-site photos. Video inspection available upon request
100% real on-site photos. Video inspection available upon request
Common Questions
ISO 13485 is the quality management system standard specifically for medical devices. It includes requirements for design control, risk management, traceability, and regulatory compliance that go beyond general ISO 9001 requirements.
ISO 13485 aligns with FDA 21 CFR Part 820 (Quality System Regulation). While certification doesn’t equal FDA compliance, the systems we maintain under ISO 13485 support your FDA submission and compliance efforts.
Yes, we maintain complete device history records (DHR) for medical device harnesses. These include all production records, inspection results, material certifications, and traceability information.
Yes, we integrate with your risk management process per ISO 14971. FMEA and risk controls identified during development are implemented and verified in our production processes.
