Quality

[ QUALITY ]

Our establishment meets all the necessary requirements to guarantee “quality.”

To meet the demand for medical device production, Histo’s quality system is certified according to ISO 13485:2016 / ISO 9001:2015.

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Each stage of the manufacturing process is carried out efficiently and in compliance with current regulations. The Class 10000 controlled zone meets the strictest health requirements and is periodically certified by its sectors.

The constant fulfillment of these tasks has allowed the granting of the certification of Good Manufacturing Practices for Medical Products (GMP) granted by the National Administration of Food, Drugs and Medical Technology (ANMAT), the approval of the registration within the F.D.A. (FOOD AND DRUG ADMINISTRATION USA – Registration No. 3004857851).

We have a team of professionals dedicated to monitoring and improving our quality system, striving to continually enhance our manufacturing methods.

The raw materials used in all our products fully meet quality standards, as they are certified at source.