Our Technical Expertise

We have a profound and outstanding expertise in the development of medical devices in compliance with FDA, CE Mark and Health Canada requirements and under the environment ISO 13485-2003. Our expertise brought on the market a significant number of class 3 and class 4 medical devices including catheters, probes, surgical clamps and medical equipments in compliance with IEC 60601.

 

Disposable Medical Devices

• Catheters : including shaft development and deflectable handle mechanism.
 
• Surgical Probes : rigid and flexible probes for minimally invasive procedures.
 
• Surgical Clamps : clamps with ablation elements or sensing elements.
 
• Medical Accessories : including sheath, connectors, cables and special accessories used to improve procedure efficiency .
 

Medical Equipment

• Electrical & Electronic Designs : Sensor measurement circuits, digital or analog design, ESD protection, overload protection, patient isolation, electrical interfaces and electrical power subsystems in compliance with IEC 60601.
 
• Mechanical Design : Human factors engineering, Industrial design, User interfaces, ESD protection, grounding and Ventilation.
 
• Software Control & User Interfaces : Friendly user interface, software control of electromechanical components, software to hardware interface, communication through the internet, system maintenance and upgrade management, Patient data management, revision control.
 
• Firmware Design : FPGA design, microcontroller design, flash memories for disposable devices.
 
• Signal Processing : Biosignal processing for special event detection or recognition.