Metecon Schweiz GmbH supports medical device and IVD manufacturers as CH-REP and EC-REP for market access in Switzerland and the EU. We guide you through the full regulatory lifecycle – efficient, tailored, and with deep expertise in RA, digitalization, AI, and cybersecurity.
Metecon Schweiz GmbH, based in Bern, is your reliable partner for achieving regulatory compliance for medical devices and in vitro diagnostics (IVDs). As your Swiss Authorized Representative (CH-REP), we support international manufacturers in accessing the Swiss market. In addition, we act as your European Authorized Representative (EC-REP) for Swiss manufacturers placing products on the EU market.
Our experienced team supports you throughout the entire product lifecycle – from technical documentation and quality management in accordance with ISO 13485 to post-market surveillance. We guide you safely through the regulatory requirements of the MDR, IVDR, and Swiss regulations (MepV and IvDV).
We also assist you in digitalizing regulatory affairs processes and offer targeted consulting for medical software, with a strong focus on artificial intelligence (AI) and cybersecurity. Together, we build efficient structures to ensure your compliance and long-term market success.
As a subsidiary of Metecon GmbH, founded in 1999 and headquartered in Mannheim, Germany, we combine deep regulatory expertise with a thorough understanding of the challenges faced by the medtech industry. Our mission is to provide you with a streamlined, secure path to market approval.
