CEpartner4U serves as consultant and Authorized Representative (AR or EC Rep) under the European Medical Device Directives 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.
CEpartner4U services include on-site and cyber consulting for all products under the Medical Device Directive (MDD), in-vitro diagnostic Device Directive (IVDD) and Active Implantable Medical Device Directive (AIMDD).
CEpartner4U is your independent Authorized Representative, confidentially maintaining your technical files and registering your Class I and IVD products with the Dutch Competent Authority.
CEpartner4U is staffed with a team of experienced Lead Assessors and medical equipment researchers.
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