KYIVGUMA has successfully completed European certification under the EN ISO 13485 standard, confirming the high level of its quality management in the field of medical devices. This is reported by the railway transport news portal Railway Supply.

KYIVGUMA has successfully completed European certification under the EN ISO 13485 standard, confirming the high level of its quality management in the field of medical devices.

The audit was conducted by TÜV AUSTRIA in April 2025. As a result, KYIVGUMA received updated certificates confirming its compliance with international standards.

KYIVGUMA’s certification covers key production areas

The confirmed scope includes the design, manufacturing, and wholesale of medical products made of rubber, silicone, and polymers. First aid kits and wound dressings are also covered by the certificate.

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The company’s internal production processes already comply with the national DSTU EN ISO 13485 standard. However, certification under the European EN ISO 13485 standard opens up new opportunities for entering the international market.

KYIVGUMA strengthens its position among global partners

The obtained certificate increases trust among clients and partners both in Ukraine and abroad. It also provides the company with greater access to international tenders and contracts.

KYIVGUMA has successfully completed European certification under the EN ISO 13485 standard, confirming the high level of its quality management in the field of medical devices.

KYIVGUMA continues to improve its quality system, aligning its operations with global management standards. This approach reinforces its reputation as a reliable medical device manufacturer.

The company plans to expand its production and export capabilities while implementing innovative solutions to enhance efficiency. Because certification is not the final goal—it is a tool for sustainable growth.

In doing so, KYIVGUMA once again proves its ability to meet the highest quality standards and maintain competitiveness in international markets.

KYIVGUMA manufactures series of under-tie and under-rail pads for Ukrainian railways, CIS countries, and European railway consumers.

About the company:

KYIVGUMA, a full-cycle company (provides services ranging from compound development and equipment design to their production). The product range includes more than 4,000 items.

On the basis of the enterprise there is a laboratory of physical-mechanical and chemical-analytical testing of materials and products, accredited by the National Agency of Ukraine for competence. KYIVGUMA not only manufactures rubber compounds or products that meet the technical parameters of the customer, the company independently develops formulations of mixtures. It ensures full compliance with all indicators ─ hardness, tensile elongation, strength, abrasion, ozone resistance, frost resistance, etc.

The production of KYIVGUMA meets the requirements of International and Ukrainian quality standards TUV SUD ISO 9001:2015, DSTU ISO 9001:2015.

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