The Clearant® technology used in our products is a process that guarantees the safety, biocompatibility and sterility of the product. It starts with a strict selection and evaluation of tissues, as well as the implementation of controls, serological detection of antigens, antibodies and molecular markers in certified laboratories for the analysis of samples of source deceased. The cleansing, debridement, cutting, measuring, packaged, freeze-dried and irradiation of the implant is done under controlled conditions, by applying quality standards in compliance with national and international regulations applicable to this type of medical devices. During these processes, qualified personnel performs monitoring microbiological tissue and facilities. Some Biograft® implants are incubated in Clearant® solution and sterilized by gamma radiation, which preserves the quality and biomechanical properties of the implants to obtain the best results in their clinical application.
Certifications
ISO 9001:2015 Certified Management System
The Quality Management System is certified in ISO 9001:2015, an international standard that focuses on the elements of quality management that we must have in order to have an effective system to manage and improve the quality of the products and services we offer; thus, for 15 years we have ratified our commitment by obtaining the highest recognition of quality, for the benefit of our customers.