Medical Wire Harness
Precision wire harnesses and cable assemblies for medical devices. ISO 13485 certified manufacturing with full traceability and regulatory compliance support.
Medical Applications
Wire harness solutions for the full spectrum of medical devices.
Patient Monitoring
ECG leads, SpO2 sensors, blood pressure, and vital signs monitoring cables
Diagnostic Imaging
MRI, CT, X-ray, and ultrasound equipment cable assemblies
Surgical Equipment
Electrosurgical, laparoscopic, and robotic surgery system cables
Laboratory Equipment
Analyzers, centrifuges, and laboratory automation wiring
Therapeutic Devices
Infusion pumps, dialysis machines, and therapy equipment
Patient Care
Hospital beds, examination tables, and patient lift systems
Precision for Patient Safety
Medical devices demand the highest levels of quality and reliability. Our ISO 13485 certified facilities deliver wire harnesses that meet the stringent requirements of the medical device industry, with full documentation and traceability.
- ISO 13485:2016 certified facilities
- FDA 21 CFR Part 820 compliant processes
- Biocompatible material options (ISO 10993)
- Sterilization compatible designs
- Full lot traceability documentation
- Design History File (DHF) support
- Risk management per ISO 14971
- Controlled environment assembly
Medical Specifications
Our medical wire harness manufacturing capabilities.
Quality That Protects Patients
Every medical wire harness we manufacture undergoes rigorous quality control. We understand that our products may be used in life-critical applications, and we take that responsibility seriously.
ISO 13485 Certified Medical Wire Harness Manufacturing for Healthcare Applications
As an ISO 13485 certified medical wire harness manufacturer, OurPCB delivers life-critical cable assemblies for diagnostic devices, therapeutic equipment, and patient monitoring systems. Our wire harness solutions meet the stringent quality and regulatory requirements of the global healthcare industry.
We manufacture medical cable assemblies using biocompatible materials compliant with ISO 10993 for patient contact applications. Our material options include medical-grade silicone, TPE, PTFE, and other FDA-approved materials suitable for sterilization via EtO, gamma radiation, or autoclave processes. Every harness includes full lot traceability documentation.
For sensitive diagnostic equipment, we provide shielded wire harness solutions with exceptional EMI rejection for MRI-compatible cables, ECG leads, and ultrasound probes. Our engineering team understands the unique signal integrity requirements of medical imaging and patient monitoring applications.
Our medical harness capabilities extend to surgical equipment cables including electrosurgical devices, laparoscopic instruments, and robotic surgery systems. We offer controlled environment assembly for applications requiring cleanroom manufacturing, and our quality system supports FDA 21 CFR Part 820 compliance documentation.
We provide complete regulatory documentation support including Device Master Records (DMR), Design History Files (DHF), risk management per ISO 14971, and certificates of conformance. Our engineering team offers design for manufacturing (DFM) analysis to optimize your custom medical cable assembly. With 48-hour prototyping and no minimum orders, we support your medical device development from concept through FDA submission. Contact us to discuss your medical wire harness requirements.
Medical Wire Harness FAQ
Yes, both our China and Philippines facilities are ISO 13485:2016 certified. This certification demonstrates our quality management system meets the requirements for medical device manufacturing, including design controls, risk management, and regulatory compliance.
Yes, we can manufacture cables using biocompatible materials that comply with ISO 10993 standards. This includes silicone, medical-grade TPE, and other materials suitable for patient contact applications. Material certifications are available upon request.
We provide comprehensive documentation including Device Master Records (DMR), Design History Files (DHF), material certifications, test reports, first article inspection reports, and certificates of conformance. We can adapt our documentation to meet your specific regulatory requirements.
Yes, our quality system and documentation practices are designed to support FDA 21 CFR Part 820 requirements. We can provide the documentation and traceability needed for your FDA submissions and registrations.
Start Your Medical Device Project
Partner with an ISO 13485 certified manufacturer for your medical wire harness needs. Full regulatory documentation support included.