Lesjöfors Expands European Medical Capabilities with ISO 13485 Certification in Sweden

Lesjöfors has reached a major milestone in its commitment to the medical technology sector by achieving ISO 13485:2016 certification at its Värnamo manufacturing facility in Sweden. This marks the first ISO 13485-certified site in Europe for the group, reinforcing its dedication to delivering high-quality, compliant solutions for medical device manufacturers.

With this certification, Lesjöfors now offers medically compliant production across all major global regions—Europe joins Asia and North America, where facilities in China, Singapore, and the USA are already certified.

Strengthening Global Reach in Medical Manufacturing The certification in Värnamo is part of Lesjöfors’ broader strategy to expand its capabilities in the medical sector. Facilities in the USA, Slovakia, and Germany are currently progressing toward ISO 13485 certification, with completion expected by late 2025 to early 2026.

To meet growing demand, Lesjöfors is also exploring investments in:

• Additional cleanroom production areas
• Advanced washing systems
• State-of-the-art automated equipment

These enhancements aim to support the increasing complexity and hygiene requirements of modern medical devices.

A Strategic Leap for Europe Wolfgang Hellmann, Head of Medical Group Sales and Business Development, emphasized the importance of this achievement:

“Securing ISO 13485 certification in Värnamo is a pivotal step for our European operations. It ensures that our medical customers across the region benefit from the same high standards of quality and compliance already established in Asia and North America. Europe now stands as a central hub in our globally certified medical network.”