Registrations we took all the way to RC
A selection of projects: from diagnostic equipment and IVD to Class 3 risk implants. Each case represents successfully passed expert evaluation, an issued Registration Certificate, and a closed dossier.
Issued registration certificates
Open a case card to view the risk class, registration timeline, key project metrics, and a description of the expert evaluation outcome.
Registration of a risk class 3 neuromodulator
The registration certificate was received without a single request for revision. The manufacturer entered the register of the VMP program and entered into contracts …
Registration of an X-ray machine of risk class 2
The registration certificate was received in 6 months - 30% faster than the market average. The device was certified and was included in the …
Registration of an AI system for analysis of chest CT scans
The registration certificate has been received. This is one of the first precedents for registering SaMD of this class in Russia. Based on our …
We will design a registration pathway for your device
Describe your device — within 24 hours we will provide the risk class, dossier structure, list of required tests, timeline, and cost through to issuance of the Registration Certificate. Free of charge, no obligations.