Trelleborg’s Costa Rican Manufacturing Site Earns ISO Certification

Trelleborg Medical Solutions’ manufacturing site in Costa Rica has achieved ISO 13485:2016 certification, helping ensure product consistency and compliance.

ISO 13485:2016 is a process-focused quality framework that ensures medical devices are designed and manufactured under controlled conditions; risks to patients and users are identified, managed, and documented; and products meet applicable regulatory requirements.

“This milestone reflects our commitment to a single and compliant quality management system across all manufacturing locations, ensuring consistent, efficient operations worldwide,” Trelleborg Medical Solutions Vice President of Quality & Regulatory Kate Bartelli said. “The certification strengthens adherence to rigorous medical device requirements, helps minimize operational risk, and enables data-backed oversight of process performance for our customers. Simply put, our people, processes, and systems are ready to support customers everywhere in the world.”

In December, Trelleborg Medical Solutions marked the grand opening of its new 107,600 square feet/10,000 square meter manufacturing facility in Costa Rica’s Evolution Free Zone Industrial Park. As the company’s first facility in Central America, it will facilitate supply chain continuity through a global manufacturing and distribution base and support key customers in nearshoring production.

“For our customers, this certification means confidence. Products made at our Costa Rica site come from a controlled, validated, and audit‑ready environment supporting faster program timelines and protecting patient outcomes,” Costa Rica plant manager Maribel Jiménez stated. “ISO 13485:2016 gives us a strong, scalable foundation to grow the right way compliantly, consistently, and as a trusted long‑term partner.”

Trelleborg Medical Solutions partners with medical device​ and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patients’ quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials, and an understanding of customer applications and end-use environments to deliver engineered solutions for health technologies.

Trelleborg leverages in-depth materials and applications expertise with early market insights, making the Group a world leader in engineered polymer solutions. The company offers a portfolio covering numerous applications. In 2024, Trelleborg Group reported approximately SEK 34 billion in annual sales, with operations in about 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions, and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is traded on Nasdaq Stockholm, Large Cap.