Successful first-time DIN EN ISO 13485 certification for medical technology devices at Leoni’s facility in Georgensgmünd
Leoni elocab GmbH passes audit without deviations
DIN EN ISO 13485 is an internationally recognised standard that harmonises the major legal requirements imposed on medical technology with the established quality management systems. By successfully passing DIN EN 13485 certification at its facility in Georgensgmünd, Leoni has proven that it fulfils its obligations with respect to product risks and how they are handled. The processes for assuring the quality of Leoni cables and cable systems for, among other things, endoscopy, ultrasound and catheter equipment with traceable documentation and risk management are enduringly effective. Leoni’s extensive range of products and services for the medical technology growth sector can be further expanded now that this certificate has been obtained.
High quality as the prime objective
LEONI elocab GmbH is a facility of Leoni’s Business Unit Healthcare, which has been developing and producing cables and cable systems for medical applications for more than 30 years. From bulk cable to individual components and through to ready-to-install systems, the developed products - most of which meeting specific customer requirements - are incorporated in an application-optimised design and taken to readiness for series production. The benchmark for every Leoni product is high quality of design with the choice of suitable materials and extensive testing. With this DIN EN ISO 13485 certification, Leoni has now proven the high product safety standards for its endoscopy, ultrasound and catheter equipment cable solutions.