ISO 13485 Certified

Medical Device Cable Assembly Manufacturing

Cable assemblies for diagnostic equipment, patient monitoring, surgical systems, and medical imaging, supported by an ISO 13485-certified quality-management system.

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ISO 13485

Medical Certified

DHR

Record Support

Lot

Traceability

ISO 10993

Evaluation Framework

Application Areas

Medical Device Applications

Custom cable solutions for the full spectrum of medical devices and equipment.

Patient Monitoring

ECG leads, SpO2 sensors, vital signs monitors

Diagnostic Equipment

Blood analyzers, lab instruments, test systems

Imaging Systems

CT, MRI, X-ray, ultrasound cable assemblies

Laboratory Devices

Microscopes, centrifuges, analysis equipment

Therapeutic Devices

Infusion pumps, ventilators, dialysis machines

Surgical Systems

Electrosurgical units, robotic surgery cables

Medical Expertise

Why Trust Us with Medical Cables

Medical equipment programs require controlled specifications, repeatable workmanship, and records that fit the customer's quality system. Our China manufacturing entity's ISO 13485-certified quality-management scope covers production of medical wire harnesses.

ISO 13485 certified quality management
Customer-defined drawings, BOMs, and acceptance criteria
Medical-grade material options evaluated for the intended use
Lot traceability and incoming-material control when specified
Cleaning and disinfectant exposure considered during material selection
EtO, gamma, or steam compatibility reviewed—not assumed
Inspection and test records matched to the quality agreement
Production-record support for the customer's DHR

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Specify for the Actual Use

Design and Material Considerations

A medical cable specification should connect patient-contact, cleaning, sterilization, flexing, and electrical requirements to the exact materials and construction.

Biocompatibility and contact

Medical-grade silicone, TPU, and PVC are candidate jacket or overmold families, not automatic proof of biocompatibility. The specific compound, colorant, processing, patient-contact category, and contact duration determine what evidence is relevant. ISO 10993 is the framework customers use to plan biological evaluation; requirements should be established before material approval.

Cleaning and sterilization compatibility

Repeated wipe-down can affect jackets, markings, adhesives, seals, and overmolded strain reliefs. If EtO, gamma, or steam/autoclave exposure is expected, the method, dose or cycle, temperature, and number of exposures should be stated. Material supplier data guides selection, followed by validation in the customer's finished-device context.

Records Defined by the Program

Quality, Traceability, and Change Control

We align cable-assembly records with the customer's drawing, purchase requirements, and quality agreement.

Incoming Material

Verify specified part numbers and retain supplier documentation when the program requires it.

Lot Traceability

Link defined materials and production lots to the assembly record at the agreed level.

DHR Support

Provide production, inspection, and test records that the customer can incorporate into its DHR.

Change Control

Control drawing and BOM revisions and route proposed substitutions or process changes for approval.

Required retention periods, serialization, report formats, and approval paths should be stated in the quality agreement; they are not identical for every program. See our cable and harness testing capabilities for available electrical and mechanical verification.

Cable Assemblies for Medical Equipment

OurPCB manufactures medical cable assemblies and wire harnesses that go into medical equipment; we do not claim to manufacture or obtain regulatory clearance for the finished device. Typical end uses include patient-monitoring equipment, diagnostic and imaging systems, surgical equipment, and laboratory or analytical instruments. For harness-specific construction options, see our medical wire harness page.

Patient-monitoring equipment can use cable assemblies for ECG leads, SpO2 sensors, and vital-sign connections. Imaging equipment such as CT, MRI, X-ray, and ultrasound systems may require shielded construction where electromagnetic interference is a design concern. Data cable construction is selected around the specified interface, bandwidth, routing, and signal-integrity requirements.

Example end uses also include electrosurgical and robotic-surgery equipment, infusion pumps, ventilators, dialysis equipment, analyzers, and laboratory automation. Where motion is expected, high-flex cable construction can be evaluated against the application's bend radius and cycle requirements. Custom cable assemblies are built to the customer's released specification.

A released specification should identify continuity, insulation, shielding, dimensional, workmanship, and any application-specific tests. Hipot or functional testing is added when the customer specification requires it. Cleaning or sterilization compatibility is treated as a material-and-construction requirement, not as a claim that every cable tolerates every process. Wire harnesses can integrate multiple connections in laboratory and diagnostic equipment.

View the certificate and registered scope on our ISO 13485 certification page. Our design support can review manufacturability against customer-controlled drawings and requirements. Contact us with the current drawing, BOM, expected environment, cleaning or sterilization exposure, test plan, quantities, and documentation requirements.

Common Questions

Medical Cable Assembly FAQ

Our China manufacturing entity holds ISO 13485:2016 certification with a scope covering production of medical wire harnesses. ISO 13485 applies to the quality-management system; it is not approval or clearance of a customer's finished medical device.

The record package can be defined around the customer drawing and quality agreement. Depending on the program, it can include incoming-material records, lot traceability, drawing and BOM revisions, inspection and electrical-test results, certificates supplied with materials, and production records that support the customer's device history record (DHR).

Biocompatibility is not a blanket property of every medical cable. We can source candidate medical-grade silicone, TPU, or PVC compounds to a customer specification, but suitability depends on the finished assembly's type and duration of contact. ISO 10993 provides the evaluation framework; the customer should define the required evidence and approve the selected material for its intended use.

Compatibility must be checked for the exact jacket, overmold, connector, adhesive, label, dose or cycle, and expected number of exposures. Candidate materials can be selected for EtO, gamma, or steam/autoclave exposure, but no material is assumed compatible without supplier data and application-specific validation. We manufacture the cable assembly; we do not claim sterilization as a service.

Start Your Medical Cable Project

Contact us to review the specifications, materials, testing, traceability, and documentation needed for the cable assembly used in your medical equipment.