El Sistema de Calidad cumple con UNI CEI EN ISO 13485:2016.
Los dispositivos IVD tienen marca CE emitida de conformidad con el Anexo III de la Directiva Europea 98/79 / CEE.
Los dispositivos médicos tienen marca CE emitida de conformidad con el Anexo II de la Directiva Europea 93/42 / CEE.
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