Leading in Medical Wiring Harnesses and Cable assemblies

Applications in Healthcare Devices

Romtronic’s cable and harness solutions power critical healthcare devices. Our assemblies connect sensors and power in MRI/CT scanners, ultrasound machines, patient monitors, infusion pumps, and various types of surgical equipment. For example, our harnesses are used in patient monitoring systems and lab instruments, linking vital-sign electrodes and data lines with precision.

• Imaging & Surgical Systems: Cables for MRI, CT, and ultrasound systems; high-speed data harnesses in X‑ray machines, surgical robots, and endoscopic equipment.

• Patient Monitoring & Therapy: Leads and cords for ECG/EEG monitors, vital sign stations, infusion pumps, and dialysis machines.

• Diagnostic & Lab Instruments: Harnesses for lab analyzers, diagnostic imaging devices, and dental equipment.

• Homecare & Wearables: Custom cables for home medical devices (infusion pumps, home monitors) and wearable health sensors. We even build harnesses for medical mobility aids and physical therapy machines.

Engineering Precision & Testing Standards

Each cable is precision-engineered for its application. We follow IPC/WHMA-A-620 and MIL-wire standards in assembly. Automated crimping machines with real-time pressure monitoring and CCD imaging inspect every connection. This attention to detail yields an industry-leading defect rate (≈0.1%). Every assembly undergoes 100% electrical and environmental testing (including bending, salt-spray, and network analyzers) to verify durability and signal integrity under harsh conditions.

Biocompatibility & Sterilization

Medical applications demand safe materials. We use biocompatible, non-toxic jacket compounds (e.g., PVC, TPU, silicone) that withstand frequent disinfection. Our cables meet ISO 10993 requirements for cytotoxicity and sensitization. For sterilizable products, we select heat-resistant materials (such as medical-grade silicone or TPE) that tolerate autoclave, EtO, or gamma sterilization. For example, silicone and thermoplastic jackets are commonly used to endure autoclave cycles. We also provide specialized shielding (foil or braid) and armored cables for EMI-sensitive equipment.

Quality & Compliance

Romtronic is ISO 13485:2016 certified for medical devices and ISO 9001:2015 certified for quality management. Our facilities are UL-listed/approved, and we comply with CE, RoHS, and FDA (21 CFR 820) regulations. We design according to AAMI/ANSI material standards and FDA guidelines, with a focus on conductor design, insulation shielding, and safe jacket materials. In short, we follow the same rigorous framework that industry leaders use: ISO 13485 compliance “results in high-quality medical device cable assemblies and wire harnesses that customers can trust”.

End-to-End Solutions

As a full-service contract manufacturer, Romtronic handles everything from concept to production. We offer design-for-manufacturing (DFM) support, prototyping, and on-demand assembly. Our team can assist with connector selection, wire routing, overmolding, labeling, and documentation. We manage component sourcing and supply-chain logistics to ensure just-in-time delivery. Whether you need a custom-length cable, a complex multi-connector harness, or a turnkey OEM/ODM production run, we have the capacity and expertise to meet your needs. (We accept small prototype orders as well as large volumes – our factory offers OEM and ODM production services.)

Customized Medical Harnesses and Cable Assemblies

Partner with Romtronic for dependable, high-quality medical wiring solutions trusted by healthcare OEMs worldwide. Contact us to discuss your medical cable and harness needs and receive a tailored solution backed by real industry expertise.