Lesjöfors strengthens European medical capabilities with ISO 13485 certification in Sweden

Marking a first for Lesjöfors’ European operations, the Värnamo site has now been certified to the internationally recognised quality management standard for medical devices – a significant milestone in the brand’s expansion of medical sector capabilities.

With Värnamo now certified, Lesjöfors’ medical compliance extends across all major regions – Europe, Asia, and North America – alongside its already established ISO 13485 certified sites in China, Singapore, and the USA.

Expanding global capabilities

Lesjöfors continues to invest in the medical sector, with additional sites in the USA and Slovakia working towards ISO 13485 certification. Completion is expected by late 2025 / early 2026. To meet future demand, Lesjöfors is also considering investments in additional clean production areas and advanced washing systems, and further state-of-the-art automated equipment.

A strategic step forward

Wolfgang Hellmann, Head of Medical Group Sales and Business Development, commented: “Achieving ISO 13485 in Värnamo is a significant milestone for our European operations. It ensures our medical customers across the region benefit from the same level of certified quality and compliance already established in Asia and North America and reinforces our role as a trusted international partner in the medical supply chain – with Europe now at the heart of our medically certified global network.”