Manufacturing news – June 2026 – Today's Medical Developments

ISO certification granted; Medical device innovation challenge
Trelleborg Medical Solutions’ manufacturing site in Costa Rica earned ISO 13485:2016 certification, helping ensure product consistency and compliance.
ISO 13485:2016 is a process-focused quality framework ensuring 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.
“For our customers, this certification means confidence,” says Maribel Jiménez, Costa Rica plant manager. “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 opened the 107,600ft² (10,000m²) manufacturing facility in Costa Rica’s Evolution Free Zone Industrial Park in December 2025.
trelleborg.com/medical
 
The U.S. Food and Drug Administration (FDA) announced the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge, which invites submissions of proposed solutions for in-home medical device technologies. The challenge aims to reduce avoidable readmissions after a hospital stay by providing options for continued care outside a hospital setting.
Innovators are encouraged to submit proposals during the submission period open until September 30, 2026. The selection period will take place between October 1 and December 4, after which participants selected to advance to the “interaction phase” will engage directly with the FDA to refine and test designs. Participants in the interaction phase will also have the opportunity to demonstrate their technology at the FDA’s research facilities. The FDA expects to select up to nine devices to move on to the interaction phase.
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