Custom medical wire harnesses engineered for patient monitoring, diagnostic imaging, surgical robotics, and in-vitro diagnostics. Built in our ISO 8 cleanroom with biocompatible materials, IPC/WHMA-A-620 Class 3 workmanship, and complete Device History Records — PCB Insider delivers medical-grade harnesses that pass regulatory scrutiny and perform in the field.
A wire harness inside a medical device is not just an electrical interconnect — it is a regulated component that directly impacts patient safety. A single crimping defect, an incorrectly rated insulation material, or a missing traceability record can trigger an FDA 483 observation, a product recall, or worse — a patient injury. The stakes are fundamentally different from commercial or industrial wiring, and your harness manufacturer must operate at that level of discipline.
At PCB Insider, medical wire harness manufacturing runs under our ISO 13485:2016 certified quality management system — the same regulatory framework used by medical device OEMs. Every harness is assembled in our ISO 8 cleanroom by IPC/WHMA-A-620 certified operators following photographed work instructions with in-process inspection gates. Complete Device History Records provide forward and backward traceability from raw material certificates through final electrical test data, ready for FDA, Notified Body, or customer audit at any time.
We are not a general-purpose wire harness manufacturer that occasionally takes medical orders. Medical device harnesses are a core business segment, and our processes — from incoming material verification through biocompatibility documentation and sterilization validation — reflect that specialization. Combined with our PCB assembly and custom cable assembly capabilities, we deliver fully integrated medical sub-assemblies under a single quality system — reducing supplier management overhead and eliminating finger-pointing between vendors when issues arise.
From patient-contact cable assemblies to high-density imaging harnesses — engineered with biocompatible materials, cleanroom assembly, and full regulatory documentation.
Multi-lead ECG/EKG cable assemblies, SpO2 sensor harnesses, blood pressure transducer cables, and patient telemetry wiring. Designed for continuous skin contact with biocompatible jacketing materials and medical-grade connectors that withstand thousands of connection cycles.
High-density wiring harnesses for MRI, CT, ultrasound, and X-ray systems. Precision shielding prevents electromagnetic interference from corrupting image data. Custom-length coiled and straight cable configurations with strain relief engineered for daily clinical use.
Ultra-flexible, lightweight wire harnesses for surgical robotics, electrosurgical instruments, and endoscopic systems. Miniaturized connectors, sterilization-resistant materials, and tight bend-radius cables that perform reliably inside articulating robotic arms.
Signal and power harnesses for laboratory analyzers, blood gas monitors, and automated diagnostic instruments. Low-noise shielded twisted pairs maintain signal integrity for sensitive measurement circuits in high-throughput IVD platforms.
Medical-grade silicone, TPU, and PTFE wire insulation and jacketing materials tested per ISO 10993 biocompatibility standards. Harnesses engineered to survive autoclave, EtO, gamma radiation, and hydrogen peroxide sterilization without material degradation.
Braided shields, foil wraps, and combination shielding architectures that meet IEC 60601-1-2 EMC requirements. Critical for ensuring medical devices operate safely alongside other equipment in hospital environments without electromagnetic interference.
Complete Device History Records linking every wire, connector, crimp, and solder joint to specific material lots, operator IDs, calibration records, and test results. Traceability from raw material certificates through finished harness — ready for FDA audit at any time.
Crimping, soldering, ultrasonic welding, and overmolding for medical connectors including Lemo, Fischer, ODU, Omnetics, and custom-designed interfaces. Pull-force testing, crimp cross-section analysis, and 100% continuity verification on every termination.
Combined wire harness and PCB assembly under one quality system. We manufacture the harness, assemble the PCB, integrate both into the housing, and perform system-level functional testing — delivering a complete medical sub-assembly ready for your production line.
| Parameter | Specification |
|---|---|
| Wire Gauge Range | AWG 36 (0.013mm²) – AWG 4 (21.2mm²) |
| Connector Types | Lemo, Fischer, ODU, Omnetics, Molex, TE, JAE, custom |
| Insulation Materials | Medical-grade silicone, TPU, PTFE, FEP, PVC (DEHP-free) |
| Biocompatibility | ISO 10993 tested — cytotoxicity, sensitization, irritation |
| Shielding | Braid (85–95% coverage), foil, spiral, combination |
| Operating Temperature | -40°C to +200°C (silicone/PTFE constructions) |
| Sterilization Resistance | Autoclave, EtO, gamma, H₂O₂ plasma — 1,000+ cycles |
| Cleanroom Class | ISO 8 (Class 100,000) — ISO 7 available on request |
| Minimum Bend Radius | 3x cable OD for flexible medical applications |
| Testing | 100% continuity, hipot (up to 5kV), insulation resistance, pull-force |
| Prototype Lead Time | 72 hours – 10 business days |
| Production Lead Time | 2 – 4 weeks (volume dependent) |
A 7-step validated production process with documented quality gates at every stage — designed for FDA and ISO 13485 compliance.
Upload your drawings, specifications, or 3D models. Our medical device engineering team conducts a comprehensive Design for Manufacturing (DFM) review alongside an FMEA-based risk assessment — identifying potential failure modes in connector selection, wire routing, strain relief design, and sterilization compatibility before a single wire is cut.
We source medical-grade wires, connectors, and insulation materials from qualified suppliers with full Certificates of Conformance and material traceability. Every material is verified against your specifications and applicable biocompatibility requirements. For custom connectors, our tooling team designs and validates injection molds per your mechanical and electrical requirements.
First-article prototypes are assembled in our cleanroom facility following the same documented procedures used for production. Prototypes undergo dimensional verification, electrical testing, mechanical pull-force testing, and flex-life testing. Design Validation testing per your DVP&R plan confirms the harness meets all functional and reliability requirements.
Detailed work instructions with step-by-step photographs are created for every assembly operation — wire cutting, stripping, crimping, soldering, routing, bundling, and final inspection. Each instruction references specific tools, fixtures, and calibrated equipment to ensure consistent results across operators and shifts.
Wire harnesses are assembled in our ISO 8 cleanroom environment by IPC/WHMA-A-620 certified operators. In-process inspection gates verify crimp heights, strip lengths, solder joint quality, and routing accuracy at defined checkpoints. Statistical process control (SPC) monitors critical characteristics in real time.
Every harness undergoes automated continuity testing, insulation resistance measurement, and hi-pot (dielectric withstand) testing. For complex medical harnesses, custom functional test fixtures simulate real-world operating conditions — verifying signal integrity, current-carrying capacity, and connector mating force across the full operating temperature range.
Visual inspection per IPC/WHMA-A-620 Class 3 workmanship standards. ESD-safe packaging with desiccant and humidity indicators for moisture-sensitive assemblies. The Device History Record is completed with all test data, inspection results, material lot numbers, and operator certifications — providing a complete audit trail from raw materials to shipped product.
Our medical wire harnesses power life-critical equipment across every major clinical and laboratory setting.
Multi-parameter patient monitors, bedside telemetry systems, fetal monitoring devices, and wireless vital signs transmitters. Harnesses designed for continuous clinical use with strain-relieved connections that survive thousands of plug-unplug cycles.
MRI coil cables, CT gantry wiring, ultrasound transducer assemblies, and digital X-ray detector harnesses. High-density shielded constructions that maintain signal integrity in extreme electromagnetic environments.
Electrosurgical pencil cables, laparoscopic instrument harnesses, surgical navigation system wiring, and operating room integration cables. Sterilization-resistant materials and sealed connectors for repeated autoclave processing.
Articulating arm harnesses, vision system cables, instrument drive unit wiring, and surgeon console interconnects. Ultra-flexible constructions with millions of flex cycles and miniaturized connectors for confined spaces inside robotic mechanisms.
Ventilator control harnesses, CPAP/BiPAP cable assemblies, anesthesia machine wiring, and oxygen sensor cables. Flame-retardant materials meeting IEC 60601-1 safety requirements for life-critical respiratory equipment.
Automated analyzer harnesses, blood gas monitor cables, PCR instrument wiring, and centrifuge control assemblies. Low-noise shielded constructions for precision measurement circuits in high-throughput laboratory environments.
“In medical device manufacturing, the quality system is not overhead — it is the product. A wire harness without full traceability, validated processes, and documented test results is not a medical-grade component, regardless of how well it's built. That's why we invest in ISO 13485 infrastructure, cleanroom assembly, and comprehensive DHRs — so our customers can focus on their device, not their supply chain risk.”
Full medical device quality management system covering design controls, risk management (ISO 14971), supplier qualification, CAPA, and management review. Audited annually by accredited registrar.
Manufacturing processes aligned with FDA Quality System Regulation requirements including production and process controls, acceptance activities, and device history records.
All medical wire harnesses built and inspected to Class 3 (high-reliability) standards — the highest workmanship class, required for medical devices, aerospace, and defense applications.
Process-level FMEA for every harness design identifying failure modes, severity ratings, and risk controls. Risk management files maintained throughout the product lifecycle as required by ISO 14971.
Wire harness assembly performed in controlled ISO 8 / Class 100,000 cleanroom environment. Particle counts monitored continuously. ISO 7 cleanroom available for implantable device components.
All wire, insulation, and connector materials sourced from UL-recognized and CSA-certified suppliers. Material Certificates of Compliance maintained on file for every production lot.
Our facility is ISO 13485:2016 certified for the design and manufacture of medical device components, including wire harnesses and cable assemblies. All operators are IPC/WHMA-A-620 certified and trained specifically in medical device manufacturing procedures. Our quality management system complies with FDA 21 CFR Part 820 (Quality System Regulation) and the EU Medical Device Regulation (MDR 2017/745). We maintain documented procedures for design controls, risk management (ISO 14971), supplier qualification, and CAPA — ready for FDA, Notified Body, or customer audits.
Yes, we routinely manufacture wire harnesses used in both Class II and Class III medical devices. Our ISO 13485 quality system and IPC/WHMA-A-620 Class 3 workmanship standards meet the requirements for high-reliability medical applications including life-sustaining and life-supporting devices. We work within your Design History File (DHF) framework, providing all required documentation — IQ/OQ/PQ validation protocols, process validation reports, and Device History Records — to support your regulatory submissions.
We use medical-grade silicone, thermoplastic polyurethane (TPU), PTFE, FEP, and DEHP-free PVC for wire insulation and cable jacketing. All patient-contact materials are tested per ISO 10993 for cytotoxicity, sensitization, and irritation. We maintain Certificates of Compliance from material suppliers and can provide biocompatibility test reports for your regulatory files. For specific applications, we source specialty materials like implant-grade silicone, radiopaque wires, and antimicrobial jacketing compounds.
Every medical wire harness we manufacture has a complete Device History Record (DHR) that traces all materials to specific lot numbers, links each assembly step to the operator who performed it and the calibrated tools used, and records all in-process and final test results. Our ERP system maintains forward and backward traceability — from raw material certificates through finished goods shipment. This traceability extends to sub-tier suppliers, so we can identify every affected unit if a material recall occurs.
We have no hard minimum — we regularly build single prototype harnesses for design verification as well as production runs of 50,000+ units per month. Medical device development cycles require flexibility, so our manufacturing setup supports quick-turn prototypes (as few as 1–5 units), pilot runs (50–500 units for clinical trials), and full-scale production. A one-time NRE fee covers test fixture development, process validation, and work instruction documentation for new harness designs.
Yes, integrated manufacturing is one of our key advantages. We manufacture wire harnesses, assemble PCBs (SMT and through-hole), and integrate both into housings or enclosures — all under one ISO 13485 quality system. This eliminates the coordination overhead and quality risks of managing separate harness and PCBA suppliers. Our system-level functional testing verifies the complete assembly, not just individual components, catching interface issues that would be missed with separate vendors.
Industrial, automotive, and general-purpose wire harnesses with IPC/WHMA-A-620 certified workmanship and automated continuity testing.
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Learn MoreUpload your drawings, specifications, or 3D models to receive a DFM review and competitive quote within 24 hours. From single prototype harnesses for design verification to validated production runs for FDA submission, our medical device manufacturing team is ready.
Quick-turn prototypes from 72 hours | ISO 13485 certified | No minimum order