Trelleborg Medical Solutions has secured ISO 13485:2016 certification for its Costa Rica manufacturing site, marking a key step in bringing the new facility into regulated medical device production.

The certification applies to the company’s site in Costa Rica, which opened in December 2025 at the Evolution Free Zone Industrial Park. The 10,000 square metre facility is Trelleborg’s first manufacturing location in Central America and forms part of the group’s wider regional supply chain strategy.

ISO 13485 is an internationally recognised quality management standard for medical device manufacturers. It is used to demonstrate that products are designed and produced under controlled conditions, with documented risk management processes and compliance systems in place.

For medical device manufacturers and outsourcing partners, certification is often a requirement before commercial production programmes can be transferred or expanded to a new site.

Kate Bartelli, vice president of quality and 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 Costa Rica site gives Trelleborg additional capacity in the Americas at a time when many healthcare manufacturers are reassessing supply chains, regional production footprints and continuity planning.

Costa Rica has continued to attract life sciences and medtech investment because of its established manufacturing base, skilled workforce and proximity to the United States market. A number of global device companies have expanded operations in the country in recent years as part of nearshoring and risk diversification strategies.

Trelleborg said the facility will support customers seeking regional manufacturing and distribution options. The company provides engineered polymer solutions and components used in medical devices, drug delivery systems and other healthcare applications.

Maribel Jiménez, Costa Rica plant manager, said: “For our customers, this certification means confidence.”

The company added that the certification supports consistent production standards across its wider global network.

For customers evaluating outsourcing and component manufacturing partners, quality certifications remain a key factor alongside scale, technical capability, lead times and geographic resilience.

The approval may also help Trelleborg compete for programmes that require validated manufacturing environments from launch.

As medtech groups continue to review supply chain resilience following recent years of disruption, additional certified capacity in Central America could become increasingly valuable.

Trelleborg did not disclose investment value, staffing numbers or planned production volumes for the Costa Rica site.