Dmitry Basalyga

Dmitry Basalyga

Deputy quality director

Responsible for the development, implementation and confirmation of a quality management system that meets the requirements of STB ISO 9001-2015, ISO 9001:2015, EN ISO 9001:2015, GOST ISO 13485-2016, ISO 13485:2016, EN ISO 13485:2016.

Performs work:

- conducting state registration and re-registration of medical equipment of own and imported production.

- confirmation of product compliance with the requirements of technical conditions, specifications, technical regulations of the Eurasian Economic Union, Directives and other regulatory requirements.

Arranged the right to apply the CE marking in accordance with the requirements of the EC Directive 93/42/EEC on medical devices for deliveries to the countries of the European Union and others.

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