Metecon GmbH
Metecon GmbH offers end-to-end support for manufacturers of medical devices and in vitro diagnostics, ensuring full compliance with regulatory requirements across the entire product lifecycle. Whether you need help with new product development, technical documentation (MDR/IVDR) creation and maintenance, verification and validation, market entry into new regions, market surveillance, or optimizing quality management processes, Metecon provides expert guidance and customized solutions.
Since 1999, Metecon has been a trusted strategic partner. Our interdisciplinary team of over 60 regulatory compliance experts delivers projects of all sizes efficiently and reliably. Additionally, Metecon assists companies in digitizing their regulatory affairs processes. We support the research, evaluation, and implementation of appropriate software solutions, saving manufacturers time and ensuring transparency at every stage. This fosters a smooth and efficient digital transformation.
CEyoo GmbH, a sister company of Metecon GmbH based in Mannheim, acts as an EU Authorized Representative (EC-REP), assuming manufacturers’ regulatory responsibilities. From efficient planning and execution to documenting quality management measures, product certification, and market surveillance, CEyoo ensures complete compliance at every stage.
For manufacturers aiming to place their medical devices on the Swiss market without a local presence, appointing a Swiss Authorized Representative (CH-REP) is crucial. Metecon Schweiz GmbH provides this service, ensuring seamless compliance with Swiss regulatory requirements.