Yes. Our entire manufacturing operation operates under a certified ISO 13485:2016 Quality Management System, and our standard product lines hold CE Marking under European Medical Device Regulations (EU MDR 2017/745). For medical device importers and OEM manufacturers in Argentina, we provide full technical dossier support—including Certificate of Analysis (CoA), Raw Material Certificates (MTRs), bio-compatibility reports, and First Article Inspection Reports (FAIR)—which streamlines the registration process with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica).