Since 1998, CEpartner4U has been a valued regulatory affairs partner of hundreds of organisations in the life sciences industry. Our services range from regulatory consultancy, authorized representation and training.
All non-EU manufacturers must appoint an Authorized Representative (AR or EC rep) in the European Community Market. As Authorized Representative, CEpartner4U is your interface with the EU Competent Authorities.
We support you and your stakeholders with the interpretation and application of the European regulations for medical devices. From self-supporting tools to extensive consultancy.
CEpartner4U is a frequent organizer of seminars and training, addressing a variety of topics including CE marking, quality management, device classification, risk management and strategy.