ANMAT: GOOD PRACTICES FOR MEDICAL PRODUCTS MANUFACTURING

Provision 3266/13 issued by the ANMAT establishes the MERCOSUR Technical Regulations for Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use. In turn, and understanding sterilization processes as a necessary part of the manufacture of a sterile medical product, compliance with this regulatory requirement is mandatory for a Company that performs Sterilization of Medical Products in Argentina to fit within the legal framework current, giving in turn the necessary legal coverage necessary to its customers. In that sense, having been Asisthos the first company of its category enabled before the Department of Medical Technology of ANMAT for the sterilization of Medical Products, we present our clients our new certificate in accordance with the last Disposition already mentioned.

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EXPOMEDICAL 2019

We will give a lecture on "How to optimize the sterilization processes for surgical instruments?" On Friday, September 27 ...

CONGRESO PANAMERICANO DE ESTERILIZACIÓN 2019

Asisthos brinda su apoyo a este evento, organizado por FUDESA, AATAE Y CLADEST; en el cual nuestro Director Técnico, Gustavo Enriquez, estará participando...

RENEWAL OF THE ISO 13485 CERTIFICATE FOR MEDICAL DEVICES

Asisthos started the path of certification of European Standards in the mid 90`s, from the UNE-EN 46002 standard. After over 20 years we have certified this...