Medizintechnik — ISO 13485

When cable quality determines human lives.

Medical devices tolerate no compromise. Our ISO 13485-certified production with laser soldering and laser stripping delivers cable assemblies that meet the highest regulatory requirements — with full traceability of every single production step.

IVUS

Intravascular ultrasound (IVUS)

Ultra-fine coaxial cables for minimally invasive vascular diagnostics. Cross-sections from 0.05mm², laser micro-soldering for contamination-free connections. Precise impedance control for artifact-free imaging.

Endoscope

Medical Endoscopes

Hybrid cables combining optical fiber, coaxial cable and control lines in one jacket. For gastroscopy, colonoscopy, bronchoscopy, cystoscopy. Precision manufacturing with laser and coaxial technology.

Surgical Robots

Cable harnesses for robot-assisted surgery (da Vinci class). Highly flexible, torsion-resistant lines for instrument arms. Sterilizable, biocompatible per ISO 10993.

Monitor

Patient Monitoring

ECG lead wires, SpO₂ sensor cables, invasive pressure measurement. Low-artifact, shielded signal lines. Patient-side isolation per IEC 60601-1 (2x MOPP).

Lab

Laboratory Analytics & Diagnostics

Cable assemblies for analyzers, centrifuges, pipetting robots, PCR cyclers. Chemical-resistant, easy to clean, ESD-protected for sensitive electronics.

Imaging

Imaging Modalities

Cable harnesses for CT, MRI, X-ray, ultrasound. RF-shielded lines for interference-free operation in strong magnetic fields. Customer-specific connector pinouts per OEM specification.

Why Mainstar for medical technology

Laser soldering + ISO 13485: rare in mid-sized companies.

Most cable harness manufacturers have either ISO 13485 or laser soldering technology. We have both — in our own factory. This makes us one of the few mid-sized players able to manufacture medical cable assemblies to the highest standards.

ISO 13485

Certified QM for medical devices

Laser Soldering

contamination-free connections

IEC 60601

patient safety 2x MOPP

UDI-ready

Traceability per MDR

Product Examples

From our production.

EKG-Ableitungskabel

10-pin ECG cable with color-coded alligator clips. Patient-side isolation per IEC 60601

Endoscope Interconnect Cable

Medical interconnect cable with precision connectors for imaging endoscopes

IVUS Coaxial Cable

Ultra-fine coaxial cable (0.39mm) with PCB connection for intravascular ultrasound

Lemo Hybrid Cable

Medical hybrid cable with Lemo connectors and RJ45. For surgical robots and imaging

Coaxial PCB Interface

Finest coaxial cable with laser soldering on PCB. For IVUS and endoscopy probes

Equipment harness

Multi-conductor harness with Molex and JST connectors for medical devices and lab analytics

Case Example

What we built for a medical device manufacturer.

Case 06 · 2024

Steuerkabel für 4K-Videoendoskop-Plattform — Wireframe-Illustration

Client · NDACustomer under confidentialityOstdeutschland · Medizintechnik

Control cable for 4K video endoscope platform

Highly miniaturized AWG-30 multi-coaxial control cable for a new 4K video endoscope — 1,000 autoclave sterilization cycles, ISO 13485, full traceability. Classic reflow soldering caused thermal stress on micro-components; laser soldering solved the problem.

0device failures / 4,500 unitsdevice failures / 4,500 units

FDA 510(k)without complaint

100 %traceability

1.200 ZyklenSterilisationsfestigkeit

View full case study →/a>

For reasons of contractual confidentiality (NDA), customer name, location and identifying details are not disclosed. Requirements and metrics are exemplary for this industry.

Cable assembly for medical technology.