Certificate of Conformity No. РОСС RU.32396.04NTC0.OS03-0131 dated August 15, 2022, issued by the responsible certification body No. РОСС RU.32396.04NTC0.OS03 MOSTEKHNORUS LLC certifies that the quality management system implemented by WestMedGroup meets the requirements of the standards ГОСТ ISO 13485–2017 (ISO 13485–2016) in relation to:
- design, production, installation, commissioning, maintenance, sale of medical instruments and equipment, components;
- production of construction and installation works;
- repair of electronic and optical equipment;
- activities related to engineering and technical design, construction project management;
- carrying out construction control and architectural supervision;
- activities for technical testing, research and analysis;
- conducting scientific research and development in the field of natural and technical sciences;
- warehousing and storage activities;
- computer software development.
Adopting the requirements of the standard allows us to ensure:
- conditions necessary to prevent the entry into the domestic market of medical equipment that does not meet the established requirements for safety, quality, and efficiency;
- timely provision of the needs of state and commercial medical institutions for modern and high-quality medical equipment;
- reducing the risk of harm to the life and health of citizens, state and municipal property, as well as the environment.
The certificate was issued based on the decision of the expert commission and is valid until August 14, 2025.
Regular version