Medical Wire Harnesses for
Medical-Grade Electronic Systems

Medical wiring harnesses are bundled wire systems that transmit signals and power within diagnostic, therapeutic and surgical equipment.

Used in Class II and III devices, medical wire harnesses must meet strict biocompatibility, sterilization, and traceability requirements.

We manufacture each harness to minimize EMI, manage strain and maintain electrical continuity across all load and flex conditions.

WellPCB builds medical wire harnesses using RoHS compliant materials, high reliability wiring techniques and workmanship standards consistent with IPC/WHMA-A-620 and ISO 9001.

RoHS-compliant wire materials for medical-grade harness builds.
Biocompatible jackets and sterilization resistant insulation.
Electrical and visual inspection for wiring accuracy and signal continuity.

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Wiring Harness Services for Medical Equipment and Devices

Medical wire harnesses organize and protect internal wiring in medical equipment, including monitoring equipment, diagnostic equipment and surgical systems.

Each harness must be able to withstand flexing, sterilization and reliable operation in clinical environments.

WellPCB manufactures custom wiring harness using RoHS-compliant materials, quality medical insulation and documented assembly methods.

Supported specifications include wire lengths up to 610 mm, strip lengths between 1 mm and 15 mm and conductor gauges from 36 to 12 AWG.

Each wire harness undergoes visual inspection to verify branch layout, label accuracy and connector placement.

Harness products are suitable for use in OEM medical devices that require precise wiring, biocompatibility and repeatable manufacturing.

Our Medical Wire Harness Capabilities

WellPCB manufactures medical wire harnesses for regulated medical equipment, delivering tested routing, labeled outputs, and connector terminations matched to device specifications. Each build uses verified medical wires and pin mappings documented for production traceability.

Signal Harnesses for Diagnostic Equipment

WellPCB manufactures signal grade medical wiring harnesses for diagnostic equipment requiring high EMI shielding and signal integrity.

Builds support stranded copper conductors in 26–20 AWG with PVC or TPE insulation, terminated into connectors using press-fit or crimp tooling.

Signal lines are shielded with aluminum-Mylar foil or 85% tinned copper braid, depending on frequency sensitivity.

Conductor pairs are twisted to reduce crosstalk in ECG, EKG, or imaging systems. Each harness is tested for continuity and insulation resistance using programmable harness testers with up to 128 test points.

Sensor-to-Logic Module Wire Harnesses

We produce compact medical wire harnesses that bridge patient facing sensors to internal control modules in medical devices.

Conductor sizes from 36 AWG to 22 AWG are supported with strip lengths controlled to ±0.3 mm. Terminals are inserted into keyed housings such as Molex PicoBlade or JST ZH, with insertion force verified using fixture based seating tools.

Medical wire harness solutions include single and multi-branch configurations with visual indicator flags and routing tags.

All harnesses undergo pinout validation and crimp height checks using calibrated micrometers to ensure accuracy.

Sterilization-Resistant Surgical Harnesses

WellPCB manufactures medical wire harnesses for surgical and patient-adjacent devices using biocompatible insulation materials such as SF302 silicone and TPE.

Jacket materials are rated for repeated autoclave cycles at 273 °F (134 °C) and meet ISO 9001 and IPC standards. Harnesses must retain jacket flexibility, strain relief adhesion, and printed label readability after up to 1,000 sterilization cycles.

ETO, gamma, and chemical disinfectant compatibility is validated through post-process inspection. Terminations use gold-plated or tin plated contacts to withstand chemical corrosion.

Electromechanical Subsystem Routing

We assemble wire harnesses for internal subsystems, including pumps, motors, actuators, and solenoids, within medical devices.

Jacket types include abrasion resistant PVC rated to 221 °F (105 °C) and halogen free blends for use in enclosed spaces. Wire and cable routing paths are controlled using P-clips, adhesive-backed mounts or overmold boots.

Terminals support pitches from 2.54 mm to 6.35 mm and are housed in latch-lock or snap-fit connectors.

Our manufacturing capabilities include cable ID mapping, positional labeling, and mechanical retention testing to ensure the durability of our services.

Biocompatible Medical Wires and Jackets

WellPCB sources medical wires from UL and CSA-approved suppliers, offering insulation options that include SF302 silicone, medical grade PVC and TPE.

All jackets are compliant with RoHS, ISO 9001, and IPC/WHMA-A-620 standards for patient-contact and fluid-contact assemblies. Each biocompatible harness undergoes material batch traceability and documentation.

Jacket options range in hardness from Shore A 50 to 90, supporting flexibility in tight enclosures. Wire insulation and shielding are validated for cytotoxicity, sensitization and leachability across finished harness builds.

Strain Relief and Retention Control

We implement mechanical strain relief features across all WellPCB wire harness assemblies using overmolded boots, adhesive wraps, and cable clamps.

Termination processes include automated and semi-automated crimping with force monitoring and crimp height tolerances held to ±0.05 mm.

Connector retention is verified through pull testing and go/no-go engagement checks. Wire harness and cable assembly inspection includes verifying bend radius and positioning for stress relief.

Connector bodies are keyed and locked using tactile or mechanical interlock features for vibration resistance.

Low-Profile, High-Density Harness Builds

WellPCB builds low profile wire harnesses for handheld, portable, and embedded medical devices using ultra flexible 28 to 36 AWG conductors.

Harness products include micro-pitch terminal sets (≤2.00 mm), flat routing for tight enclosures, and bendable branch paths with a spacing of 3 mm or less.

Medical wire harnesses must pass form-fit tests using routing templates and mockups. All terminations are checked for mechanical clearance, connector mating force, and retention.

Labeling is done using etched sleeves or low profile adhesive tabs to support miniature packaging.

Prototyping Through Lot-Based Manufacturing

WellPCB supports medical harness builds from prototype development through lot-based manufacturing.

OEMs can submit cable drawings, connector specifications, and pinout tables for harness builds governed by traceability and inspection standards.

Harness or cable assembly lots are serialized with label maps, inspection logs and documented test results.

Lead times for medical wire harness prototyping begin at 2 to 3 weeks and are confirmed on a project-by-project basis.

All builds are validated through continuity, insulation resistance, and pinout verification using multipoint testers.

Why Choose WellPCB for Your Medical Wire Harness?

WellPCB produces medical wire harnesses entirely in house, from wire cutting and terminal crimping to connector mating, testing, and labeling.

By controlling every step on-site, including material sourcing and inspection, we reduce coordination delays and prevent traceability gaps. Each build is processed, verified and documented within a single facility to meet the strict reliability and regulatory demands of medical equipment OEMs.

WellPCB delivers full-service medical wire harness production, from sourcing medical wires and verifying pinouts to final harness and connector assembly.

This vertically integrated process eliminates vendor fragmentation and supports rapid transition from BOMs or 3D drawings to finished medical equipment builds.

The consolidated workflow preserves traceability across wire routing, connector mating, and final inspection, reducing risk during scale-up for OEMs in regulated medical environments.

WellPCB’s wire harness production operates under ISO 9001:2015-certified manufacturing systems that cover wire cutting, terminal crimping, insulation

displacement, and connector mating.

Every operation is backed by traceable documentation and linked inspection points to confirm lot consistency.

These certified workflows control material tolerances, stripping lengths, and crimp force calibration across high volume wire harness assemblies used in monitoring systems and diagnostic medical devices.

We source connectors and materials through global distributors including Arrow, Mouser, and Avnet.

All medical wires and jackets used in

WellPCB harnesses are built from RoHS-compliant materials, including halogen free and low smoke options compatible with sterilization.

For patient-adjacent or in-contact builds, jackets can be specified to meet ISO 9001 biocompatibility standards.

WellPCB supports dense wire harness configurations using 36–28 AWG medical wires routed to miniature sensors and fine pitch connector

interfaces. Automated cutting, crimping, and bundling maintain uniform harness geometries across lot runs.

All builds are labeled using shrink tubing or permanent ID tags and validated for spacing and bend radius compliance, ensuring compliance with the packaging demands of embedded medical equipment and diagnostic platforms.

Every WellPCB wire harness is manufactured to IPC/WHMA-A-620 Class 3 standards for high-reliability medical applications.

These standards define conductor preparation, insulation stripping, crimp height tolerances, and mechanical pull testing.

In addition to workmanship criteria, all assemblies are validated for long term performance through continuity testing, insulation resistance measurements, and connector retention checks conducted after sterilization and flex cycle simulation.

These procedures confirm that each harness maintains electrical and mechanical integrity over its expected service life in medical field conditions.

Each medical wire harness build is assigned a serialized lot number linked to traceable inspection records, pinout diagrams, and component sourcing logs.

Compliance documentation is archived with each project to support regulatory audits, OEM process validation, and long term serviceability requirements.

Harness records include labeling maps, test result sheets, and quality acceptance logs, which are maintained in accordance with regulated medical equipment documentation standards.

Our Medical Harness Manufacturing Process

At WellPCB, we manufacture medical wire harness assemblies using tightly controlled production steps that meet the quality systems and procedures required within the medical industry. Every process is traceable, repeatable, and designed to support OEM documentation requirements for FDA submission readiness.

Every build begins with a review of the bill of materials (BOMs), schematics, and cable routing tables. Our engineering team validates netlists, connector mating diagrams, and pinout

definitions before production. This stage confirms compatibility across all connector types used in different types of medical equipment, including patient monitors, infusion pumps and imaging systems.

We match medical wire and jacket materials to OEM specifications, including RoHS-compliant and ISO 9001 insulation where required. Crimp terminals are selected based on wire gauge,

contact rating, and sterilization compatibility for body-adjacent medical applications. Materials meet traceability requirements for finished medical builds and compliance-ready device integration.

Each medical wire harness is assembled on form boards with mechanical taping, spot tie-offs, and multipoint routing control. Wires are automatically cut and stripped to exact lengths.

Conductor ends are prepared for crimping or insertion using semi-automated equipment. Marking and printed ID sleeves are applied during wire processing to support pinout alignment and connector sequencing. Crimping is performed with calibrated press tooling, and each joint undergoes pull-force and crimp-height checks per fixture group.

Assembled medical wire harness assemblies are tested for continuity, insulation resistance, and pinout accuracy using test fixtures with up to 128 points per station.

Pull testing and polarity checks are documented to support regulatory compliance for the operation of medical devices. Each harness or cable assembly is verified against electrical and mechanical test plans.

Final custom medical wire harness assemblies are labeled with serialized IDs, connector tags, and visual maps for traceability. Packaging includes inspection checklists, label legends,

and batch records aligned with FDA documentation formats. All records support audit readiness, service tracking, and quality systems and procedures required by the manufacturer of medical wiring harness operations.

What are the Design Considerations for Medical Wire Harnesses?

Medical wire harness design must account for sterilization resistance, biocompatibility, mechanical strain protection, and documentation traceability to meet healthcare compliance standards.

These factors determine whether a custom medical cable assembly performs reliably across the full lifecycle of regulated diagnostic and surgical devices.

Jacket material must be selected based on the sterilization method used, including autoclave (134 °C), ETO gas, gamma radiation, or chemical disinfection.

Materials must resist embrittlement, discoloration, and loss of flexibility after repeated exposure.

Biocompatibility requirements include ISO9001, RoHS-compliant, UL, and IPC standards.

Suitable compounds include SF302 silicone and TPE for use in assemblies for medical equipment and devices.

Medical wire harness designs must incorporate features that redirect mechanical stress away from terminals and connectors.

These include molded boots, grommet exits, and defined flex zones.

Pull force thresholds and connector retention must be validated using mechanical fixtures to prevent disconnection or damage in high movement healthcare applications.

Signal carrying conductors within harnesses must be shielded to minimize EMI, crosstalk, and signal degradation. Layout constraints include shield

routing continuity, drain wire terminations, and controlled spacing between analog and digital lines.

EMI design is critical in diagnostic probes and dental equipment. The shielding method affects the overall diameter of the custom medical cable and the termination procedure.

The medical wire harness layout must accommodate internal clearances, mating connector orientation, and enclosure fastening points.

Design limitations include minimum spacing

between branches, defined standoff distances, and cable clamp positions.

Custom layout templates may be required to create custom routing paths that conform to compact assemblies or sterilization-safe housings.

Routing geometry must include bend radius minimums based on conductor gauge and insulation hardness.

Fold zones and strain absorbing loops must be planned in assemblies subjected to

repeated motion.

Adhesive backed mounts and form board anchor points define stable paths in miniaturized cable harness builds for embedded control units.

Labeling requirements include color coded conductors, etched ID sleeves and connector tags mapped to the device schematic.

Documentation must track each wire and cable used per harness, support serialization,

and align with quality systems and procedures for regulated production.

Traceability records must be maintained across all finished medical assemblies.

What Medical Applications and Industries do We Support?

WellPCB manufactures wire harnesses and cable assemblies for original equipment manufacturers (OEMs) producing patient monitors, ultrasound systems, infusion pumps, defibrillators, ventilators, and robotic surgical devices. These assemblies support Class II and III medical equipment that require insulation certified to ISO 9001 and RoHS-compliant materials.

How to Order Your Medical Wire Harness

Submit Your Design

Send us your design details (Drawing or Detailed Specifications).

Get a Fast Quote

Once your design and specs are received, a fast quote will be sent to you within 24 hours.

Confirm Order & Make Payment

When the quotation is approved, please send the PO or order confirmation, we will proceed with the production after receiving your payment.

Arrange Production & Inspection

Before production, our technical team will review all details of the drawing/specs again. If everything is OK, the order will start. We'll keep you updated throughout the manufacturing process. After the production is completed, the products will be 100% inspected.

Packaging & Delivery

When completed, your order will be carefully packed and shipped to you, with shipping documents and tracking information provided.

WellPCB is trusted by millions of
businesses and innovators.

Why Choose WellPCB as Your Wire Harness Manufacturer?

WellPCB stands out among USA wire harness manufacturers by delivering superior quality, advanced solutions, and unmatched reliability. With years of experience serving global markets, WellPCB has earned a reputation as one of the top wire harness manufacturers in the USA.

WellPCB specializes in custom wire harnesses for complex electronic and industrial applications. You can order these assemblies with $100 off using our special offer—delivering high-quality, tailor-made harnesses at competitive rates for your most demanding projects.

Hommer Zhao

Founder and Chief Editor – Hommer Zhao

Welcome! I’m Hommer Zhao, the founder and Chief Editor of WellPCB. With years of experience in the PCB industry, I’m committed to making sure our content is both accurate and helpful. We’re proud to serve a growing community of over 4,000 customers worldwide, and our goal is to provide you with the best resources and support. Your satisfaction is our top priority, and we’re here to help you every step of the way!

Jesse Holland

Technical Manager – Jesse Holland

Hi, I’m Jesse Holland, an Engineer and Technical Manager at WellPCB. With years of experience in PCB design and engineering, I’m here to ensure that every project we work on meets the highest technical standards. I lead our team, focusing on precision and innovation, collaborating closely with clients to provide tailored solutions and expert guidance. Whether you’re facing a complex design challenge or need advice on technical aspects, I’m here to ensure your project is a success from start to finish.

Nathan Jensen

Purchasing Manager – Nathan Jensen

Hi, I’m Nathan Jenson, the Purchasing Manager at WellPCB. I’m responsible for sourcing the best materials and components to ensure our products meet the highest quality standards. With my extensive experience in procurement, I work closely with suppliers to secure reliable and cost-effective solutions while maintaining strong relationships to support our operations. I aim to ensure every project runs smoothly by providing the resources needed to deliver on time and to your satisfaction.

Emma

Sales Manager – Emma

Hey, I am Emma, sales manager at WellPCB. I studied electronic science and technology at university and have served customers for PCB and PCB Assembly service for several years. 
I enjoy communicating with customers and our technicians to solve problems, and customers always say, "It's great to have you onboard". 
It is my pleasure and honour to be helpful. Contact me now, and you'll know.

Bella and Cassiel

Sales Representatives – Bella and Cassiel

We’re Bella and Cassiel, your dedicated sales representatives at WellPCB. With our extensive knowledge of the PCB industry, we’re here to provide exceptional service and support. We take the time to understand your unique needs and are always ready to offer tailored solutions and advice. Whether you need product recommendations, assistance with your orders, or simply have a question, we’re here to ensure your experience is smooth and seamless at every step.

Mandy and Wendy

Sales Representatives – Mandy and Wendy

We’re Mandy and Wendy, your friendly sales representatives at WellPCB. Passionate about helping our customers, we bring a wealth of experience in the PCB industry to provide you with the best solutions and service. We take pride in building strong relationships with our clients, understanding their specific needs, and offering personalised support to ensure their satisfaction. Whether you’re looking for advice, product information, or assistance with any part of your order, we’re here to make your experience as smooth and efficient as possible.

Our Team

Our skilled engineers and technicians bring expertise and precision to every PCB assembly project. Committed to quality, efficiency, and innovation, our team ensures every order meets the highest UL, IPC, ROHS & REACH standards, delivering reliable solutions tailored to your needs.

Founder and Chief Editor – Hommer Zhao
Technical Manager – Jesse Holland
Purchasing Manager – Nathan Jensen
Sales Manager – Emma
Sales Representatives – Bella and Cassiel
Sales Representatives – Mandy and Wendy

All Wire Harness Services

Medical Wire Harness Case Studies

Wiring Harness

Terminal Wiring

In medical devices, the reliability and safety of terminal wiring are crucial.

We can produce terminal wiring that meets specific quality and safety requirements.

Specifications:

•Voltage: Up to 1000V
•Current: Up to 15A
•Temp Range: -25°C to +125°C
•Wire Type: Stranded tinned copper
•Insulation: Medical-grade PVC/XLPE
•Termination: Crimped or soldered
•Standards: UL, RoHS, ISO 13485

Wiring Harness

Medical Wire Harness

Custom-engineered wire harnesses ensure reliable connections in imaging systems and patient monitoring, offering flexibility, biocompatibility, and easy integration.

The wire harnesses we produce are widely used in:

Medical monitor: ECG machine, Blood Pressure Monitor, EEG machine
Medical imaging devices: CT scanners, MRI machines, X-ray machines
Diagnostic equipment: Ultrasonography, Blood Sugar Analyzer, etc.

PCB Assembly

Robotic Cable

Used in medical robotic solutions and cable systems. Optimized for precision and flexibility, our Robotic Cable enhances performance in surgical robots, ensuring durability, sterilizability, and seamless signal transmission.

Specifications:

•Voltage: 300V
•Temp Range: -40°C to +150°C
•Flex Cycles: >10 million
•Shielding: 90% braid
•Jacket: Medical-grade TPU
•Sterilization: Autoclave compatible

Medical Wire Harness Client Feedback

As an R&D manager, I have had an outstanding experience working with WELL-PCB. For many years, our company has entrusted them with the production, assembly, and programming of the boards developed in our R&D unit, and they have consistently exceeded our expectations.

Their work is very impressively perfect. Today, when they check our company PCB board after assemble. They found a fake short point which many engineers has never found in the past years. But that is just designed so. The PCB board quality is excellent. Their service is also excellent.

My friend introduced WellPCB to me, the first try, a little look forward to. I ordered a 47*72 10ps PCB, and I can’t wait to receive my PCB. So I used expedited service and received my PCB in three days. I tested and soldered the PCB, Quality is really good, silkscreen, plating also great.

Medical Wire Harness FAQs

What are the Conductor Materials and Shielding Technologies?

We use stranded copper conductors in sizes ranging from 36 to 12 AWG, with silver-plated copper available for high performance builds. Shielding options include foil, braided copper, or combined foil-braid designs to suppress electromagnetic interference (EMI). These are selected based on signal requirements and applied across our medical cable assemblies and wire harness solutions.

What testing protocols and standards do your medical harnesses meet?

Our medical wire harnesses are tested for continuity, insulation resistance, crimp height and pull force using up to 128-point testers. All assemblies are built to IPC/WHMA-A-620 Class 3 workmanship standards and use materials that comply with UL and ISO 9001, and RoHS-compliant specifications.

How are Your Medical Harnesses Built for Long-Term Reliability and Failure Prevention?

Each wire harness is manufactured with retention tested connectors, calibrated crimping, and controlled routing to minimize mechanical stress. Assemblies undergo insulation resistance, pull force, and continuity testing across multiple points. These practices help prevent failure from flex fatigue, sterilization cycles and connector wear in regulated medical applications.

How do you handle packaging, labeling, and FDA documentation?

Each medical wire harness is labeled with serialized IDs, connector tags, and layout legends for lot tracking. Packaging includes inspection logs and label maps formatted for FDA documentation. These records support regulated shipment, traceability, and post market service for finished medical devices.

What connector types can be included in your wire harness builds?

We support a wide range of connector types, including Molex PicoBlade, JST ZH, and other micro-pitch housings. Crimped, press-fit, and locking connectors are terminated using calibrated tooling, with insertion force and pin alignment verified during assembly. These options support compact custom medical wiring harness builds across diagnostic and therapeutic platforms.

Medical Wire Harnesses for Medical-Grade Electronic Systems

Wiring Harness Services for Medical Equipment and Devices

Our Medical Wire Harness Capabilities

Why Choose WellPCB for Your Medical Wire Harness?

One-Stop Wire Harness Manufacturing for Medical Equipment

Certified ISO 9001 Process Control and Assembly Workflows

RoHS-Compliant Harness Materials

High-Density Wire Routing and Miniaturized Layouts

IPC/WHMA-A-620 Assembly Standards for Medical Harness Builds

Lot-Based Documentation, Compliance Records, and Retention Tracking

Our Medical Harness Manufacturing Process

Engineering Review & Routing Table Validation

Jacket & Terminal Material Selection (Biocompatible, RoHS)

Harness Assembly on Fixture (Taping, Lacing, Crimping)

Quality Testing: Pull, Continuity, Isolation

Serialization & Packaging for FDA Submission Readiness

What are the Design Considerations for Medical Wire Harnesses?

Biocompatibility and Regulatory Compliance

Strain Relief Geometry & Retention Testing

EMI Isolation for Mixed-Signal Wiring

Routing Constraints in Class II/III Medical Devices

Bend Radius, Fold Zones, and Mechanical Anchoring

Color Coding, Labeling, and Documentation Flow

What Medical Applications and Industries do We Support?

Patient Monitoring Systems

Diagnostic Imaging Equipment

Surgical and Electromechanical Devices

Therapeutic/Life-Support Equipment

Home Healthcare and Portable Systems

Dental Equipment Wiring