Authorised European Representative service enabling non-EU medical device manufacturers to achieve regulatory compliance and market access across EEA member states. Provides CE marking registration, EUDAMED database documentation, and Free Sales Certificate support for medical devices and in vitro d...
Manufactured by
Prolinx GmbH
Düsseldorf, Germany
Prolinx Consulting helps worldwide exporters to gain global market access. Prolinx Consulting is an industry leading consultancy company specialised in Business Services and Regulatory Affairs such as: Authorised European Representative and CE Marking. A world-leading consultancy offers you excellent services at competitive prices!
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EUCEREP B.V. · Netherlands
EU Authorized Representative and UK Responsible Person service supporting non-EU medical device manufacturers with regulatory compliance, CE marking, EUDAMED registration, technical documentation review, and Quality Management System establishment for European market access.
Obelis Group S.A. · Belgium
EU Authorised Representative service enabling medical device manufacturers and importers to demonstrate regulatory compliance with EU MDR/IVDR requirements. Provides expert guidance on EU, UK, US, and Swiss regulatory pathways for medical devices, in vitro diagnostics, and cosmetic products. Facilitates market access and post-market surveillance documentation.
Maven Profcon Services LLP · India
Regulatory consulting service supporting medical device manufacturers with EU MDR, US FDA 510(k), and UKCA certification compliance. Provides technical documentation preparation, conformity assessment, and audit support to streamline CE marking and regulatory approvals.
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