Turnkey medical device registration in the RF and EAEU with guaranteed issuance of the Registration Certificate.
We provide a full-cycle market entry for medical devices: from risk classification and Technical Specification (TS) development to clinical trials and obtaining the final Registration Certificate. We work with all risk classes (I, IIa, IIb, III) and Software as a Medical Device (SaMD).
-
Compliance with Decision No. 46: Registration under the latest EAEU regulations with error-free dossier preparation.
-
In-house Testing Department: We facilitate technical, toxicological, and clinical testing in accredited laboratories.
-
Transparent Timelines: Realistic issuance forecasts based on the regulator’s current workload.
-
Legal Safeguards: We assume financial liability for the result, as explicitly stated in our contract.
Get price quote and estimated duration for medical device registration
order free document audit for medical device registration
