Medical Cable Manufacturer — ISO 13485 Certified OEM Assemblies

Nexharn Connectivity is a trusted medical cable manufacturer supplying precision cable assemblies and interconnect solutions to medical device OEMs, contract manufacturers, and healthcare equipment integrators worldwide. As a dedicated medical cable supplier, we combine deep engineering expertise with rigorous quality systems to deliver cables that meet the demanding performance, safety, and regulatory requirements of the medical device industry.

Medical Cable Assemblies: Quality Supporting Patient Safety

As a leading medical cable assembly manufacturer, Nexharn understands that every connection in a medical device is safety-critical. Our medical cable assemblies are engineered to deliver consistent, reliable electrical performance in diagnostic, therapeutic, and patient monitoring applications. From single-conductor patient leads to complex multi-conductor sensor assemblies, our products are designed and manufactured to meet IEC 60601-1 medical electrical equipment standards.

Nexharn operates under an ISO 13485-certified quality management system, the internationally recognized standard for medical device manufacturing. Our ISO 13485 certification demonstrates our systematic approach to risk management, design controls, process validation, and post-market surveillance — giving medical device OEMs confidence when qualifying a medical cable supplier.

Medical Cable Types We Manufacture

As a full-service medical cable manufacturer, Nexharn produces a comprehensive range of medical cable types:

Patient Monitoring Cables

• ECG/EKG Lead Wires – 3-lead, 5-lead, and 12-lead configurations with snap, clip, or disposable electrode connections; latex-free, biocompatible jacketing
• SpO2 Sensor Cables – Pulse oximetry extension cables and sensor assemblies compatible with Masimo, Nellcor, and Philips platforms
• NIBP Hose Assemblies – Non-invasive blood pressure tubing and cable combinations for bedside monitors
• Temperature Probe Cables – Thermocouple and thermistor-based temperature measurement cables for patient temperature monitoring

Imaging and Diagnostic Cables

• Ultrasound Transducer Cables – Highly flexible micro-coaxial assemblies with lemo or custom connector terminations for diagnostic ultrasound probes
• Endoscopy Cables – Light guide and video signal cables for rigid and flexible endoscope systems
• MRI-Compatible Cables – Specialized RF-shielded and fiber optic cables designed for high magnetic field environments

Surgical and Electrosurgical Cables

• Electrosurgical Unit (ESU) Cables – High-voltage, high-frequency cables for monopolar and bipolar electrosurgical applications
• Laparoscopic Instrument Cables – Reusable and single-use cable assemblies for minimally invasive surgical systems
• Robotic Surgery Cables – High-flex, high-cycle life assemblies for robotic-assisted surgical platforms

Therapeutic Device Cables

• TENS/EMS Therapy Leads – Transcutaneous electrical nerve stimulation and muscle stimulation cables for pain management and rehabilitation
• Defibrillator Cables – High-energy discharge-rated cables for AED and manual defibrillation systems
• Infusion Pump Cables – Power and communication cables for IV infusion and syringe pump platforms

ISO 13485 Quality Management System

Nexharn’s ISO 13485-certified quality management system provides the framework for consistent, controlled medical cable manufacturing. Key elements of our QMS include:

• Design Controls – Structured design and development process per 21 CFR Part 820 and ISO 13485 Section 7.3
• Risk Management – ISO 14971 risk management process applied to all medical cable designs
• Process Validation – IQ, OQ, and PQ validation of all critical manufacturing processes including crimping, soldering, overmolding, and testing
• Supplier Controls – Approved vendor list management, incoming inspection, and supplier audit programs
• Complaint Handling – Structured CAPA system with root cause analysis and preventive action tracking
• Full Traceability – Lot traceability from raw material receipt through finished product shipment

Material Compliance and Biocompatibility

As an experienced medical cable assembly manufacturer, Nexharn selects and qualifies materials meeting:

• ISO 10993 – Biological evaluation of medical devices, including cytotoxicity, sensitization, and irritation testing
• RoHS Directive 2011/65/EU – Restriction of hazardous substances in all materials
• REACH Regulation – Compliance with SVHC reporting requirements
• UL 13 and UL 62 – Flexible cord and cable standards for medical device power cables
• Latex-Free Materials – All patient-contact jacketing materials are latex-free

Testing Capabilities

Nexharn’s in-house testing laboratory supports comprehensive qualification and production testing of medical cable assemblies:

• Electrical continuity and resistance testing (100% of production)
• Hi-Pot / dielectric withstand testing to IEC 60601-1 requirements
• Insulation resistance measurement
• Flex life cycle testing (100,000+ cycles)
• Pull-out force and strain relief testing
• Dimensional and visual inspection per IPC-A-620C medical standard
• Sterilization compatibility testing (EtO, autoclave, gamma, hydrogen peroxide plasma)

Medical Device Applications

Nexharn’s medical cable assemblies serve critical roles across a broad spectrum of medical device categories:

• Patient Monitoring – ICU bedside monitors, telemetry systems, wearable health monitors
• Diagnostic Imaging – Ultrasound, CT, MRI, X-ray, and PET imaging systems
• Surgical Systems – Electrosurgical units, laparoscopic systems, robotic surgery platforms
• Cardiovascular Devices – Catheter lab equipment, cardiac rhythm management, AED systems
• Neurology – EEG systems, nerve conduction study equipment, neurostimulation devices
• Rehabilitation – Physical therapy equipment, TENS units, functional electrical stimulation
• Home Healthcare – Home ECG monitors, remote patient monitoring, home infusion

Why Choose Nexharn as Your Medical Cable Supplier

Medical device OEMs choose Nexharn as their medical cable supplier because we combine engineering depth, regulatory expertise, and manufacturing flexibility:

• ISO 13485 Certified – Systematic, auditable approach to medical device quality
• Regulatory Support – Technical file documentation, DHF/DMR support, and FDA 510(k) submission support
• Custom Engineering – Purpose-built cable assemblies designed to your exact specifications
• Rapid Prototyping – Engineering samples typically available in 2-4 weeks
• NDA-Protected Development – All customer projects managed under strict confidentiality
• Scalable Supply – From clinical trial quantities to full commercial production volume

Ready to partner with a proven medical cable manufacturer and medical cable assembly manufacturer? Contact Nexharn’s medical device engineering team to discuss your project requirements, request a quote, or arrange a capabilities review.