The Ukrainian manufacturer KYIVGUMA has secured coveted EN ISO 13485 certifications, validating the company’s robust quality‑management system for medical devices, according to industry outlet Railway Supply.
TÜV AUSTRIA Audit Confirms Compliance
In April 2025, independent auditors from TÜV AUSTRIA conducted a comprehensive assessment of KYIVGUMA’s facilities. Their verdict? Full alignment with European quality requirements—resulting in freshly issued certificates that underscore KYIVGUMA’s commitment to excellence.
Broad Certification Scope
The new accreditation spans the design, production, and wholesale of medical items crafted from rubber, silicone, and advanced polymers. It also covers first‑aid kits and wound‑care dressings, ensuring every stage—from concept to distribution—meets stringent European standards.
From National to European Standards
While KYIVGUMA already operated under Ukraine’s DSTU EN ISO 13485 guidelines, achieving the European version of the standard opens doors to broader markets and tougher tenders. This milestone not only boosts credibility with international partners but also expands the company’s eligibility for lucrative global contracts.
Strengthening Trust with Partners Worldwide
The EN ISO 13485 badge fortifies customer confidence, enhancing KYIVGUMA’s reputation as a dependable, world‑class medical‑device maker. Clients at home and abroad can now point to an internationally recognized benchmark when choosing KYIVGUMA as their supplier.
Continuous Improvement & Future Growth
Certification is not an endpoint for KYIVGUMA—it’s a launchpad. The firm is streamlining operations, adopting innovative technologies, and scaling both production and export capacity to meet rising demand while maintaining elite quality levels.
Proven Competitive Edge
By consistently meeting—and often surpassing—global standards, KYIVGUMA cements its role as a competitive player in the international medical‑device arena.
Beyond Healthcare: Precision Components for Rail
In addition to medical products, KYIVGUMA manufactures a range of under‑tie and under‑rail pads for rail operators throughout Ukraine, the CIS region, and Europe, showcasing the company’s versatility and engineering prowess.
SOURCE-https://www.railway.supply/en/kyivguma-receives-en-iso-13485-quality-certificate/
