An Approach to Digital Transformation of the Registration Expertise of Devices using Blockchain Technologies

In the article, the authors conducted an extensive study of the current situation with the use of digital transformation tools in the life cycle management system of medical devices based on the blockchain. The analysis showed that blockchain technology is being actively implemented in two directions: in the field of supply chain management of medicines, products, equipment and in the field of ensuring the security of medical data exchange in the digital space. It is concluded that at the moment an ideal blockchain-based system has not yet been formed to solve the problem of supervision of the supply chain of medical devices. In this study, attention is paid to the development of recommendations for organizing the possibility of submitting documents for the registration dossier of medical devices to the state body by using the possibilities of electronic document management and blockchain technology.

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Publication Details

Published
2025-04-08
DOI
https://doi.org/10.1109/reepe63962.2025.10971170
Primary Topic
Economic and Technological Systems Analysis
Type
article
Field-Weighted Citation Impact
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article

An Approach to Digital Transformation of the Registration Expertise of Devices using Blockchain Technologies

Maria E. Yakovleva, A. I. Antonov
Economic and Technological Systems Analysis
article

An Approach to Digital Transformation of the Registration Expertise of Devices using Blockchain Technologies

Maria E. Yakovleva, A. I. Antonov
article en

Abstract

In the article, the authors conducted an extensive study of the current situation with the use of digital transformation tools in the life cycle management system of medical devices based on the blockchain. The analysis showed that blockchain technology is being actively implemented in two directions: in the field of supply chain management of medicines, products, equipment and in the field of ensuring the security of medical data exchange in the digital space. It is concluded that at the moment an ideal blockchain-based system has not yet been formed to solve the problem of supervision of the supply chain of medical devices. In this study, attention is paid to the development of recommendations for organizing the possibility of submitting documents for the registration dossier of medical devices to the state body by using the possibilities of electronic document management and blockchain technology.

Bauman Moscow State Technical University (RU)
Openalex Percentile: Top 86%
Economic and Technological Systems Analysis
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