Medical device CE marking

Medical Device CE marking

For more than 20 years, CEpartner4U has been a valued partner of hundreds of organizations worldwide. Our services range from regulatory strategy and compliance to clinical evaluation, authorized representation (EC REP), and training.

Cepartner4u

 
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CEpartner4U as Representative

All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within the Union. As AR, CEpartner4U is your interface with the EU Competent Authorities.

 
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Consultancy

CEpartner4U supports you and your stakeholders with the interpretation and application of the European Regulations for medical devices, from self-supporting tools to extensive consultancy.

 
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Training

CEpartner4U frequently organizes seminars and training, addressing a variety of topics including CE marking, quality management, device classification, risk management, and strategy.