Ellecom GmbH
Ellecom GmbH, based in Efringen-Kirchen in Baden-Württemberg, specializes in regulatory solutions and market access in the fields of in-vitro diagnostics and medical technology. Ellecom GmbH has expertise and competence in the fulfillment of demanding regulatory requirements in an international context and supports its customers in the implementation and tracking of regulatory and technical documentation. Ellecom also supports its customers in the introduction of a QM system in accordance with the ISO 13485:2016 and ISO 9001:2015 standards.
Ellecom GmbH designs and implements customer-specific regulatory projects to meet the requirements of Notified Bodies and the relevant national and international health authorities.
In addition to its expertise in regulatory solutions, the company is also active in the business areas of trading in medical devices and trading in electronic components. Ellecom GmbH works with manufacturers from various parts of the world who specialize in the manufacture of medical products and in-vitro diagnostics. Ellecom GmbH is certified according to ISO 9001:2015 and ISO 27001:2017.
Ellecom is EU Authorized Representative as well as Swiss Authorized Representative for medical device manufacturers through Ellecom Swiss AG.