Registration of medical software (software) is carried out if the software product has a clear medical purpose — it is used for diagnosis, monitoring of the patient's condition, support for medical decision-making, or other clinical tasks.
Medical software includes, in particular, clinical decision support systems (CDSS) and other diagnostic or analytical digital solutions.
A separate direction is the registration of medical software with elements of artificial intelligence (AI). Such solutions require additional evaluation of algorithms and the correctness of the recommendations provided.
Special attention is paid to clinical trials, which confirm the effectiveness and safety of the software product.
The procedure for registering medical software includes:
-
Preparation of technical and operational documentation — description of architecture, algorithms, interface, etc.
-
Conducting the necessary tests — technical, toxicological (if integrated with equipment), and clinical studies confirming effectiveness.
-
Formation and electronic submission of the registration dossier — interaction with expert organizations and the registration authority.
The procedure is applicable to all types of software solutions that perform diagnostic, therapeutic, or auxiliary functions in medical practice.
In our portfolio — registered medical software products, including solutions with artificial intelligence. We have experience interacting with leading clinical centers, including the N.N. Blokhin National Medical Research Center of Oncology and the Almazov National Medical Research Center.
