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Metecon GmbH represents experience and expertise in Regulatory Compliance: Since 1999, Metecon have been a strategic partner located in Mannheim, assisting Creation and maintenance of product files for medical devices and IVD, at the Verification and validation of these products, for all aspects of Clinical Affairs und Regulatory Affairs as well as with the optimization of Quality management processes.

With Metecon Switzerland, we now offer this proven service cycle to our Swiss customers on-site as well as to manufacturers of medical devices and IVDs looking to place their products on the Swiss market: Metecon Switzerland represents regulatory consultation and support in accordance with all relevant requirements, ensures manufacturers from the EU and other markets safe access to the Swiss market as a Swiss Authorized Representative (CH-REP).

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CEyoo GmbH, a sister company of Metecon, temporarily takes on the role of Legal Manufacturer for medical technology companies that want, to handle their regulatory affairs processes more efficiently, i.e. CEyoo takes over the regulatory tasks and duties of a manufacturer. including efficient planning, execution and documentation of quality management and market monitoring as well as all associated liability risks.

For non-EU manufacturers planning market access in European market, Ceyoo, acts as an EU Authorized Representative (European authorized representative, EU-REP/EC-REP), takes on the regulatory responsibilities in the EU in accordance with MDR/IVDR Art. 11.

Wondering if CEyoo can make an economic difference for you? Let's find out!