Certifications

EPSA – Electroplast S.A. holds the main international certifications that endorse the quality, safety and efficacy of its medical devices.

ISO 13485

Our quality management system is certified under ISO 13485, the international standard specific to the medical device industry. This certification ensures that our design, production and distribution processes comply with the highest quality and traceability requirements.

CE Marking

EPSA products carry the CE mark, certifying their conformity with applicable European directives for medical devices. This certification enables the commercialization of our products throughout the European Union and all markets that recognize the European standard.

GMP — Good Manufacturing Practices

We follow Good Manufacturing Practices (GMP) across all our production processes, ensuring controlled manufacturing conditions, quality raw materials and rigorous controls at every stage of production.

ANMAT — National Regulatory Approval

EPSA is authorized by ANMAT (Uruguay's National Administration of Medicines, Food and Medical Technology) for the manufacture and commercialization of medical devices in both national and international markets.