ISO 13485:2003

Sensortechnics Certifies Its Consultation, Design, Development and Production Processes According to ISO 13485:2003

Sensortechnics is a leading company in the development and manufacture of high quality sensors, custom sensing solutions as well as fluidic control systems. For more than 25 years the company has been recognised as a worldwide design and development partner for its customers in the medical market. Sensortechnics' experienced engineers offer extensive technical support, proof of concept and convert customers' requirements into an initial concept and technical specification. The actual development phase includes the calculation, possible simulation and build-up of prototypes. Following the verification according to customers' specifications the design is transferred to serial production. Sensortechnics' modern production facilities are flexible enough to build small volume quantities as well as offer cost-effective highly automated serial production in cleanroom environments. The complete process is subject to a quality management system with comprehensive control and documentation requirements which is now certified according to ISO 13485:2003. Regular quality and customer audits as well as the annual surveillance by the certification body ensure the control and continuous improvement of the quality management system.

Sensortechnics' product range includes pressure, level, flow, oxygen, force and air bubble sensors as well as miniature solenoid valves and pumps. In addition to single sensor solutions, the company develops and manufactures complex multi-sensor boards and complete OEM-modules which can integrate e.g. sensors, valves, pumps, microcontrollers, reservoirs and accumulators. For these systems Sensortechnics is able to provide control circuits and define analog or digital interfaces for integration into OEM devices.

Sensortechnics' products are ideally suited for many demanding and critical medical OEM device applications such as e.g. ventilators, respirators, sleep apnea monitors, oxygen concentrators, anaesthesia and dialysis machines. Medical device manufacturers use Sensortechnics' application specific products to shorten their design cycle time, save development costs and achieve fastest innovations to market.

June 2009
Sensortechnics press photo ISO 13485:2003
Downloads
If you need further information please contact Sensortechnics.
-
Product note list