ISO 13485 Certified
ISO 13485:2016 certified quality management system for medical device wire harness and cable assembly with risk management and regulatory compliance support.
Medical Device Requirements
Key medical device quality system elements we implement.
Risk Management
ISO 14971 risk analysis integration
Design Control
Controlled development process
Traceability
Complete material and process tracking
Validation
Process and equipment validation
Documentation
Device history records (DHR)
Regulatory
FDA and global regulatory support
Built for Medical
Medical devices require special attention to safety, traceability, and regulatory compliance. ISO 13485 certification ensures we have the systems medical device companies require.
- Medical device quality system
- Risk management integration
- Design and development control
- Validated manufacturing processes
- Complete traceability
- Device history records (DHR)
- Controlled documentation
- Regulatory compliance support
Certification Details
Our ISO 13485 certification information.
Patient Safety First
Medical device harnesses can impact patient safety. ISO 13485 certification ensures we treat every medical harness with the care and documentation it deserves.
Validated
Proven processes
Traceable
Complete records
Controlled
Documented procedures
Compliant
Regulatory support
ISO 13485 Certified Medical Device Wire Harness Manufacturing
As an ISO 13485 certified manufacturer, OurPCB produces medical wire harnesses and cable assemblies with the quality systems required for medical device applications. Our medical device quality management system integrates risk management per ISO 14971 and supports FDA regulatory compliance.
Design control processes ensure proper development validation for medical device cables. Complete device history records (DHR) provide full traceability from materials through finished product. Testing capabilities include hipot testing for patient safety and environmental testing for reliability verification.
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. UL certification provides additional safety verification. Quality systems ensure consistent medical cable production.
Both our China and Philippines facilities maintain ISO 13485 certification. Labeling and packaging supports medical device requirements. Contact us to discuss your medical device wire harness and regulatory compliance needs.
ISO 13485 FAQ
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.
Medical Device Partner
ISO 13485 certified wire harness manufacturing for medical devices with risk management and regulatory compliance support.