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 a class IIb X-ray system
The registration certificate was received in 6 months - in 6 months. The device was certified and was included in the supply catalog for …
Registration of an AI system for analysis of chest CT scans
The registration certificate has been received. Based on our methodology, the customer subsequently registered 2 more models from his line in half the time.
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.