Andrey Antonov

Expert in medical device registration, regulatory strategy, and digitalization of registration processes

Andrey Antonov is the founder and CEO of KREDOTECH, an expert in medical device registration in Russia and the EAEU, test organization, registration dossier preparation, and building end-to-end regulatory processes.

He has worked in medical device registration since 2017. In 2019, he founded KREDO with the goal of bringing documentation preparation, testing, sample logistics, and interaction with Roszdravnadzor together into a single, manageable process.

His practical background includes registration projects and testing infrastructure. Experience building and managing laboratory projects allows him to view medical device registration not only as a matter of preparing documents, but also in terms of how technical documentation, testing, evidence, and regulatory requirements interconnect.

At KREDOTECH, Andrey is responsible for the company's development strategy, complex and non-standard registration projects, growing the partner infrastructure, and introducing artificial intelligence into the analysis and preparation of medical device registration documentation.

Under his leadership, KREDOTECH's digital ecosystem continues to develop, combining expert work by specialists, AI-assisted preliminary document analysis, test organization, laboratory selection, and sample logistics.

Andrey regularly writes and speaks as an expert on medical device registration, changes in regulatory practice, the use of artificial intelligence in regulated processes, and the digital transformation of healthcare.

Core areas of expertise: medical device registration in Russia and the EAEU; registration strategy; registration dossier preparation; medical device testing; interaction with Roszdravnadzor; regulatory risk; artificial intelligence in medical device registration; healthcare digitalization.

Area of responsibility at KREDOTECH: company strategy, complex registration projects, development of the digital ecosystem, partnerships, and the introduction of new technologies.