EU regulatory compliance and market access services for medical device manufacturers, including authorized representative designation, MDR/IVDR registration, and CE marking documentation to facilitate entry into European markets.
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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3 of 114 closest product alternatives
Johner Institut GmbH · Germany
Regulatory consulting and software solutions enabling medical device manufacturers to navigate compliance requirements and accelerate market entry. Supports device classification, documentation, and regulatory strategy across EU and international markets.
MedNet EC-REP GmbH · Germany
Authorized Representative services for Class I to Class III medical devices under MDR 2017/745, providing comprehensive EU regulatory compliance and market access.
Maven Profcon Services LLP · India
Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, FDA 510(k) clearance, and UKCA certification processes. Provides technical documentation preparation, conformity assessment, risk management, and audit support to ensure compliance with EU MDR, EU IVDR, and UK regulatory requirements.
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