Empresa

Certifications

ANVISA/MS 80255120001

ANVISA – AFE ANIVSA/MS UHH44W1Y3549

GMP (Good Manufacturing Practices for Medical Products according to RDC #59, dated 27/June/2000) – currently in implementation.


Bionext® is currently waiting for the following certifications:

ISO 13485 - Gerenciamento de sistemas de qualidade para dispositivos médicos/Requisitos para fins regulamentares

ISO 14.000