BEO BERLIN supports manufacturers of medical devices with regulatory requirements.
We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.
We implement regulatory requirements for you by evaluating and preparing individual documents, complete documentations or applications.
We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.
Clinical Evaluation: If you plan to sell your medical devices in Europe, you must create and maintain a Clinical Evaluation Report (CER) that meets the requirements of the MDR.
The economic actors; manufacturers, importers and EU-REPs have to register in EUDAMED since this year. Products can currently only be registered by notified bodies.
The standard VDE 0750-2-52 is at the pre-standard stage
The product group 54 “Nursing aids intended for consumption” of the Nursing Aids Register is currently being updated by the GKV-Spitzenverband.
We are looking back at the this year’s updates to the Hilfsmittelverzeichnis.
BEO BERLIN advises manufacturers of medical devices on testing and approval procedures for market access.
Your quick reference for the most important specialist terminology and keywords.
