Trelleborg Medical Solutions’ manufacturing site in Costa Rica has earned 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.
Kate Bartelli, Vice President of Quality & Regulatory, says: ‘This milestone reflects our commitment to a single and compliant quality management system across all manufacturing locations ensuring consistent, efficient operations worldwide. 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.’
Maribel Jiménez, Costa Rica Plant Manager, says: ‘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. 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 celebrated 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 in December 2025. 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.
