ISO 13485:2016 Compliant Process

ISO 13485 Compliant Medical
Wire Harness Manufacturer

As a precision medical wire harness manufacturer, we engineer fail-safe cable assemblies for patient monitoring, imaging, and surgical equipment. We utilize bio-compatible materials and adhere to strict cleanroom standards.

Manufactured to ISO 13485 Standards

Medical cable assemblies demand zero failure rates. Cablum operates under a strict Quality Management System tailored for the medical industry.

Quality Commitment: Our production strictly follows Quality Testing standards to ensure zero defects and full traceability (ISO 14971) for every life-critical assembly.

Bio-Compatibility

Materials meeting ISO 10993 (USP Class VI) standards.

Sterilization Ready

Jackets withstand Autoclave, ETO, and Gamma sterilization.

Signal Integrity

Low-noise shielding for sensitive ECG/EEG signals.

Ergonomic Design

Soft-touch finishes for handheld diagnostic probes.

Medical wire harness manufacturing in an ISO 13485 compliant cleanroom environment

Medical Applications

Trusted solutions for diagnostics, monitoring, and therapy.

Diagnostic Imaging

High-speed data harnesses for CT, MRI, and Ultrasound systems.

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Patient Monitoring

SpO2 sensors, ECG leads, and temperature probe assemblies.

Consult Engineer

Surgical & Therapy

Cables for electrosurgical units, endoscopy, and dental lasers.

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Technical Specifications

General capabilities for medical grade assemblies.

Feature Specification Range
Conductor Size 36 AWG to 18 AWG (Micro-Coax down to 46 AWG)
Insulation Materials Medical Grade PVC, TPE, TPU, Silicone, FEP, PTFE
Sterilization Autoclave (134°C), EtO, Gamma Radiation
Bio-Compatibility ISO 10993, USP Class VI
Protection Rating Up to IP67/IP68 via our Custom Overmolding

Medical Success Stories

Proven reliability in critical healthcare applications.

quality testing
quality testing

IPC/WHMA-A-620 Class 3 Certified World-Class Wire Harness Testing Lab Zero defects is our standard. Our comprehensive wire harness testing and quality control...Read More...

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Case Study: High-Voltage EV Charging Harness
Case Study: High-Voltage EV Charging Harness

Home Case Studies Automotive EV Case Study: High-Voltage EV Charging Wire Harness Assembly Read our case study on manufacturing a zero-defect high-voltage...Read More...

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Case Studies
Case Studies

Global Engineering Capabilities Custom Wire Harness Case Studies & Projects Connectivity Across Industries. From 800V EV platforms to microscopic surgical robotics. Explore...Read More...

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Featured Medical Interconnects

Bio-compatible medical sensor cable assembly

Bio-Compatible Sensor Cable

Silicone/TPU jacket for skin contact.

  • Latex-free & USP Class VI
  • Flexible & Soft-touch
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Fine-wire micro coaxial cable assembly for medical endoscopy

Fine-Wire Micro Coax

For endoscopy and catheter applications.

  • AWG 36-46 Micro Wires
  • High-Density Termination
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Design for Medical Compliance

Our engineers understand the regulatory landscape. Let us help you bring your medical device to market faster with ISO 13485 compliant manufacturing.