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.
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.
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.
CEpartner is there 4U to train you on regulatory affairs, quality management and clinical evaluation. We can arrange for on-site training or by video conference.
