Medical Device Cable Assembly Manufacturing
Precision cable assemblies for diagnostic equipment, patient monitoring, surgical systems, and medical imaging. Our ISO 13485 certified facilities deliver the quality and reliability critical to medical applications.
Medical Device Applications
Custom cable solutions for the full spectrum of medical devices and equipment.
Patient Monitoring
ECG leads, SpO2 sensors, vital signs monitors
Diagnostic Equipment
Blood analyzers, lab instruments, test systems
Imaging Systems
CT, MRI, X-ray, ultrasound cable assemblies
Laboratory Devices
Microscopes, centrifuges, analysis equipment
Therapeutic Devices
Infusion pumps, ventilators, dialysis machines
Surgical Systems
Electrosurgical units, robotic surgery cables
Why Trust Us with Medical Cables
Medical devices demand the highest levels of quality, reliability, and regulatory compliance. Our ISO 13485 certified facilities and experienced team deliver cable assemblies that meet these critical requirements.
- ISO 13485 certified quality management
- FDA 21 CFR Part 820 compliance
- Biocompatible material options (ISO 10993)
- Full traceability and lot control
- Cleanroom assembly capabilities
- Sterilization compatibility (EtO, gamma)
- Risk management documentation
- Design history file support
ISO 13485 Certified Medical Device Cable Assembly Manufacturing
As an ISO 13485 certified medical cable assembly manufacturer, OurPCB delivers precision cable solutions for diagnostic equipment, patient monitoring, and surgical systems. Our cable assembly expertise covers medical-grade cables with biocompatible materials (ISO 10993), FDA 21 CFR Part 820 compliance, and full lot traceability for Class I, II, and III medical devices.
Patient monitoring cables connect ECG leads, SpO2 sensors, and vital signs equipment requiring consistent electrical performance and patient safety. Imaging system cables for CT, MRI, X-ray, and ultrasound demand shielded construction to prevent EMI interference. Our data cables handle high-speed digital connections between imaging sensors and processors.
Surgical device cables support electrosurgical units, robotic surgery systems, and therapeutic equipment including infusion pumps, ventilators, and dialysis machines. High-flex cables withstand repeated bending in handheld surgical instruments. Custom cable assemblies meet unique device requirements.
Cleanroom assembly capabilities support sterile device manufacturing. Cables are compatible with EtO and gamma sterilization methods. Our testing capabilities include hi-pot safety testing, bioburden verification, and functional testing. Wire harnesses integrate multiple connections in laboratory and diagnostic equipment.
View our ISO 13485 certification for medical quality management details. Our design support team assists with design history file (DHF) documentation. Contact us for medical cable assembly quotes with risk management support.
Medical Cable Assembly FAQ
We are ISO 13485 certified for medical device quality management. Our products are manufactured in compliance with FDA 21 CFR Part 820 requirements, and we maintain full biocompatibility documentation for relevant materials.
Yes, our ISO 13485 certified quality system supports cable assemblies for Class I, II, and III medical devices. We provide full traceability, risk management documentation, and validation support as required.
Yes, we can manufacture cables using biocompatible materials certified to ISO 10993 standards. This includes medical-grade silicone, PVC, TPE, and other materials suitable for patient-contact applications.
All medical cables undergo 100% electrical testing, hi-pot testing, and visual inspection. Additional testing includes bioburden testing, EtO sterilization compatibility, and specific functional tests based on device requirements.
Related Products & Services
Medical Grade Cable
ISO 13485 compliant cables
ProductsShielded Cable
EMI protection for sensitive devices
CertificationsISO 13485
Medical quality certification
CapabilitiesQuality Testing
Comprehensive testing services
ServicesPrototyping
Rapid prototype development
ServicesDesign Support
DFM and engineering support
Start Your Medical Cable Project
Our team understands the regulatory requirements of medical device manufacturing. Contact us for expert guidance on your cable assembly needs.