Medical Device Wire Harness & Cable Assemblies
Precision wire harness manufacturing for medical and healthcare devices. Biocompatible materials, cleanroom assembly, and regulatory compliance support.
- ISO 13485 & IEC 60601 compliant
- Biocompatible materials (ISO 10993)
- Class 10,000 cleanroom assembly
- FDA registered facility
Medical Device Applications
Precision cable assemblies for a wide range of medical and healthcare equipment
Patient Monitoring
ECG, vital signs monitors, pulse oximeters, blood pressure monitors
- 12-lead ECG cables
- SpO2 sensors
- Temperature probes
- Respiratory monitors
Diagnostic Equipment
Imaging systems, laboratory analyzers, testing devices
- Ultrasound probes
- Lab analyzers
- Blood gas analyzers
- Point-of-care devices
Surgical Instruments
Powered surgical tools, electrosurgical units, minimally invasive devices
- Electrosurgical units
- Powered drills/saws
- Endoscopic cameras
- Robotic surgery
Therapeutic Devices
Infusion pumps, dialysis machines, ventilators, CPAP
- IV infusion pumps
- Dialysis systems
- Ventilators
- Nebulizers
Imaging Systems
X-ray, MRI, CT scan, ultrasound, mammography equipment
- MRI coil cables
- CT detector cables
- X-ray generators
- Ultrasound transducers
Portable Devices
Handheld diagnostics, home monitoring, wearable devices
- Glucose monitors
- Portable ultrasound
- Defibrillators
- Wearable monitors
Medical Device Compliance & Quality
Regulatory standards and quality systems for medical device manufacturing
Regulatory Standards
- ISO 13485:2016 certified facilities
- IEC 60601 electrical safety compliance
- Biocompatibility testing (ISO 10993)
- RoHS and REACH compliance
- FDA registered facility (Australian)
- CE marking documentation support
- TGA (Therapeutic Goods Administration)
- 21 CFR Part 820 Quality System
Quality Features
- Biocompatible materials (medical-grade)
- Class 10,000 cleanroom assembly
- Full lot traceability and control
- 100% electrical testing (hi-pot, continuity)
- Design History File (DHF) support
- Sterilization compatible materials
- Statistical Process Control (SPC)
- Supplier qualification program
Medical-Grade Manufacturing Capabilities
Advanced cleanroom facilities and precision equipment for medical device cable assemblies
Precision Crimping Equipment
Automated crimping machines with precision control for medical-grade terminal connections
Medical Assembly Line
Dedicated cleanroom production lines for medical device cable assembly with controlled environment
Medical Testing Equipment
100% electrical testing, hi-pot testing, and medical device validation procedures
Controlled Wire Processing
Precision wire cutting and stripping in controlled environment for medical applications
Medical QC Area
Dedicated quality control stations with medical device inspection systems and traceability
Trained Medical Team
ISO 13485-trained technicians with expertise in medical device manufacturing
Quality Certifications & Medical Standards
ISO & IATF certified manufacturing with medical device quality management capabilities
ISO 9001:2015 Certified
Internationally recognized quality management system ensuring consistent product quality.
IATF 16949:2016 Certified
Automotive quality management certification demonstrating high-reliability manufacturing.
ISO 13485:2016 Certified
Medical device quality management system for medical wire harness production.
Medical Compliance & Standards
Frequently Asked Questions
Common questions about medical device wire harness manufacturing
Are your facilities ISO 13485 certified for medical devices?
Yes, our manufacturing facilities are ISO 13485:2016 certified for medical wire harness production. We maintain comprehensive quality management systems, cleanroom environments, and full traceability documentation required for medical device applications.
What biocompatible materials do you use?
We use biocompatible materials tested per ISO 10993 standards, including medical-grade silicone, TPE, and specialized jacket materials. All materials are documented with certificates of compliance and biocompatibility test reports.
Can you support IEC 60601 electrical safety requirements?
Yes, we design and manufacture cable assemblies meeting IEC 60601 electrical safety standards for medical electrical equipment, including proper insulation, leakage current limits, and patient protection measures.
Do you offer cleanroom assembly?
Yes, we have Class 10,000 (ISO 7) cleanroom facilities available for medical device cable assembly, with proper environmental controls, gowning procedures, and particle monitoring.
What documentation do you provide for medical devices?
We provide comprehensive documentation including Design History Files (DHF), certificates of conformance, material certifications, test reports, lot traceability, and support for Design Control per 21 CFR Part 820.
Can cables withstand sterilization processes?
Yes, we can specify materials compatible with common sterilization methods including autoclave (steam), EtO (ethylene oxide), gamma radiation, and chemical sterilization. Material selection depends on your specific sterilization requirements.
Do you support FDA-regulated medical device manufacturing?
Yes, our facilities are FDA registered and we follow Good Manufacturing Practices (GMP). We support customers with FDA 510(k) submissions and can provide necessary documentation and validation support.
What is your experience with patient safety critical applications?
We have extensive experience with safety-critical medical applications including patient monitoring, life support equipment, and implantable device connections. All products undergo rigorous testing and validation.
Cost Optimization & Supply Chain Solutions
Beyond manufacturing - strategic support to reduce costs and ensure supply continuity
Long-Term Cost Reduction
Strategic component optimization for sustainable savings
Alternative Component Sourcing
Our sales managers can recommend cost-effective alternative models from Chinese suppliers that meet the same specifications - often reducing component costs significantly.
Custom Mold Development
For high-volume requirements, we can develop custom molds tailored to your exact needs. While there's an upfront investment, this dramatically reduces per-unit costs for long-term production runs.
Inventory Management Services
Never miss a deadline with our stocking solutions
Pre-Stocking for Critical Orders
If you have strict delivery requirements or seasonal demand peaks, we recommend pre-stocking key assemblies. Our extensive factory space can accommodate your inventory needs.
Material Management Support
For your most important orders, we provide comprehensive material management - ensuring components are ready when production begins, eliminating supply chain delays.
Speak with Our Melbourne Manager
Discuss cost optimization, inventory solutions, and custom component sourcing with Mark, our local Australia manager based in Melbourne.
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Partner with ISO 13485 Certified Medical Device Manufacturer
Regulatory compliance support, biocompatible materials, precision manufacturing
Melbourne Office: 1/30 Seaford Road, Seaford VIC 3198 | Mon-Fri 9AM-6PM