CEpartner4U serves as consultant and Authorized Representative (AR or EC Rep) under the European medical device regulations for hundreds of manufacturers from all over the world. From longstanding experience, we understand the dynamics of CE marking. As Authorized Representative, we consider it our privilege and duty to monitor your regulatory position in Europe.

In our capacity, we advise manufacturers, importers, distributors and other stakeholders about the interpretation and application of the European regulations for medical devices. 

We serve an important customer base with classified content. Our IT supplier is ISO27001:2017 certified and is up to date with the latest developments in the security space. CEpartner4U understands that security measures are key for a safe workspace and has developed a stringent IT policy to that effect.

Founded in 1998, CEpartner4U has matured to a well-known and respected organization. CEpartner4U is staffed with a team of experienced lead assessors and medical device researchers.

CEpartner4U has a branch office in the UK, UKCApartner4U, providing UK Responsible Person services. 
Apart from that, we offer Swiss Representative services.

CEpartner4U

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CEpartner4U

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