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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RAPIDEZ Y EFICIENCIA EN ESTERILIZACIÓN POR ÓXIDO DE ETILENO

Optimizamos los tiempos para los materiales esterilizados por óxido de etileno.

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...

A TOY FOR A SMILE

Every year, Asisthos SRL celebrates the arrival of the Holudays with the "One Toy for a smile" project, donating toys for children who are hospitalized.