Medical-Grade Cable Assemblies & Wire Harnesses for Healthcare Devices
WireAssyTech manufactures precision cable assemblies for surgical robots, patient monitoring systems, diagnostic imaging equipment, and wearable health devices — built to IPC-A-620 Class 3 standards with full traceability documentation.
Cable & Harness Capabilities for Medical Applications
Every medical cable assembly we manufacture is built to withstand rigorous sterilization cycles, EMI environments in imaging suites, and continuous-flex demands of robotic surgery arms.
Precision Signal & Ribbon Cables
Multi-conductor signal cables for patient monitoring leads, ECG/EEG electrodes, and sensor arrays. Shielded twisted pairs for noise immunity in high-EMI environments.
Connector: LEMO, Hirose, Molex · Impedance: 50–120Ω
IP67/IP68 Overmolded Cables
Watertight cable assemblies for surgical instruments, washdown environments, and sterilization-compatible connections. Injection-molded connectors eliminate ingress points.
Sterilization: EtO, Gamma compatible
Continuous-Flex Cables for Robotics
High-cycle-life cables for surgical robot arms and motorized positioning systems. Engineered for torsion, bending, and repeated articulation without conductor fatigue.
Material: Stranded ETFE, PUR jacket
Box Build & Electro-Mechanical Assembly
Full sub-assembly for medical equipment enclosures: PCB integration, wire harness routing, connector labeling, and functional test before shipment.
CE/FCC marking coordination available
RF & Coaxial for Imaging
Low-loss coaxial assemblies for ultrasound transducers, MRI surface coils, and endoscope camera links. Precision impedance control to minimize signal degradation.
Connector: SMA, SMB, FAKRA, MCX
Custom Wire Harness for Patient Monitoring
Multi-branch wire harnesses for bedside monitors, infusion pumps, and ventilators. Color-coded conductors, labeled branches, and IPC Class 3 solder joints.
Labeling: heat-shrink print, laser mark
Medical Sub-Sector Solutions
Detailed specifications and design guides for specific medical device categories.
Surgical Robotics
Continuous-flex cables and shielded signal assemblies for da Vinci-style robot arms and laparoscopic tools.
Patient Monitoring Systems
ECG leads, SpO₂ sensor cables, and multi-branch harnesses for ICU and bedside monitoring equipment.
Diagnostic Imaging
RF coaxial assemblies for ultrasound probes, MRI coils, and X-ray detector signal chains.
Wearable Health Devices
Ultra-fine gauge cables (36–30 AWG), lightweight jacketing, and biocompatible materials for wearable biosensors.
Certifications We Build To
Our quality documentation package is designed to support your FDA 510(k), CE marking, and ISO 13485 audit requirements from day one.
| Standard | Scope | How We Comply |
|---|---|---|
| IPC-A-620 Class 3 | Workmanship standard for wire harness and cable assemblies — highest reliability class | All operators certified; solder joints, terminations, and routing inspected per Class 3 acceptance criteria |
| ISO 13485 | Medical device quality management system | Process controls, CAPA system, supplier qualification, and DHR documentation aligned to ISO 13485 requirements |
| IEC 60601-1 | Electrical safety for medical electrical equipment | Hi-pot dielectric withstand test (1500–3000 VAC per spec); leakage current measurement on patient-connected cables |
| UL Listed | North American market safety certification | UL-listed wire and components used; UL file documentation provided |
| RoHS / REACH | Hazardous substance restriction for EU market | Full material declaration; CoC with RoHS compliant material confirmation per batch |
| FDA 21 CFR 820 | US Quality System Regulation for device manufacturers | DHR packages compatible with QSR audit: lot records, process parameters, test results, operator sign-off |
From Design to Validated Production
We support the full medical device development lifecycle without requiring you to switch suppliers at each stage.
DFM Review
Engineering review of your drawings. We flag manufacturability issues before tooling is cut.
Prototype (48h)
First articles delivered within 48–72 hours. Dimensional report and electrical test included.
DVT / PVT Support
We supply production-representative samples for your design and process validation testing.
Process Lock
Manufacturing process frozen with work instructions, fixture photos, and control plan.
Production + DHR
Each lot ships with full Device History Record: materials, test data, operator records.
Proven Results
Continuous-Flex Cable Assembly for 6-Axis Surgical Arm
A European surgical robotics OEM needed flex cables capable of 5 million bend cycles without conductor fatigue at a ×4 OD bend radius. WireAssyTech developed an ETFE-insulated, PUR-jacketed solution with individually shielded signal pairs. Prototype delivered in 3 days; production validated within 6 weeks. The assembly passed IEC 60601-1 dielectric and touch-current tests on first submission.
Frequently Asked Questions
Technical questions our medical device customers ask most often.
- Autoclave (134°C steam): Silicone-jacketed cables
- EtO (ethylene oxide): TPU and PVC cables
- Gamma radiation: PTFE-insulated cables
- Liquid chemical (e.g. glutaraldehyde): TPU and silicone
- PVC — cost-effective, UL/CSA rated
- TPU — flexible, chemical-resistant, good for repeated flexing
- PTFE / ETFE — sterilization-compatible, low outgassing, very fine gauge capable
- Silicone — autoclave-rated up to 200°C, very flexible
Ready to Start Your Medical Cable Project?
Have a medical wire harness design? We protect your IP. We gladly sign NDAs before reviewing your schematics. Upload your 2D drawings (PDF) or 3D models (STEP/IGS) today.
Upload Your Drawings & Get Quote