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Registration Number

0217U001843, 0116U002627 , R & D reports

Title

Definition of institutional and financial burden of conformity assessment procedures of medical devices in the introduction of new technical regulations

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Head

Kozіuk Viktor Valeriyovych,

Registration Date

04-07-2017

Organization

Ternopol National Economic University

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The object of research is the process of introducing new technical regulations on the market of medical products.The purpose of the work is to substantiate theoretical and methodological principles and develop practical recommendations for the formation of an optimal model for assessing the conformity of medical products in Ukraine on the basis of the introduction of technical regulations, which is considered as one of the priority directions of regulation in the context of the implementation of the economic part of the Association Agreement between Ukraine and the European Union .Methods of work - dialectical and formal-logical methods (analysis and synthesis, abstraction, generalization, induction and deduction, analogy, modeling); Concrete-scientific (measurement, comparison, experiment, formalization, hypothetical-deductive, ascent from abstract to concrete) and special-scientific (economic-mathematical, statistical, expert) methods of economic research.The generalized scientific results of the work are methodical recommendations for optimization of procedures for assessing the conformity of medical products in the process of introduction of new technical regulations. The scientific novelty of the work is to develop scientifically grounded approaches to the formation of an optimal model for assessing the conformity of medical products in Ukraine on the basis of the introduction of EU technical regulations. The practical value of the study. The research-based recommendations developed in the course of the research to optimize the procedures for assessing the conformity of medical products in the process of introduction of new technical regulations may be used by operators of the market of medical products and regulators of this market.

Product Description

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Гайда Юрій Івановичч
Мельник Юлія Віталіївна
Підгурська Ірена Андріївна

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2020-04-02