Trelleborg Medical Solutions has announced that its manufacturing site in Costa Rica has been awarded ISO 13485:2016 certification, affirming product consistency and compliance.
ISO 13485:2016 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices.
It specifies requirements that help organisations ensure their medical devices meet both customer and regulatory standards for safety and effectiveness.
Kate Bartelli, Vice President of Quality & Regulatory, said: "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 minimise 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, added: "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 programme 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.
The company celebrated the opening of its new 107,600 sqft manufacturing facility in Costa Rica's Evolution Free Zone Industrial Park in December of last year.
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.