Obtaining the ISO 13485:2016 International Certificate By One of the Knowledge-Based Company Located In the Royan Biotechnology Incubator Center
Kian Immune Cell succeeded in obtaining the international standard certificate 2016: ISO 13485.
According to the public relations and international affairs report of Royan Institute, Kian Immune Cell company, which is one of the Knowledge-based companies located in the Royan Biotechnology Incubator Center, has succeeded in obtaining the international standard certificate 2016: ISO 13485 for their product that is used to detect drug resistance in cancer patients at an early stage.
This certificate has been awarded as an international certificate by the ISO international standard organization for a knowledge-based product called "Chemobiogram Kit".
Scientific research has shown that one of the major issues faced by cancer patients is the development of drug resistance after treatment. The main reason behind this is the presence of treatment-resistant cells, which leads to the failure of chemotherapy and radiation therapy in such patients.
A "chemobiogram kit" is a tool that helps doctors determine the most effective drug combination for a patient before prescribing medication. By using the patient's tumor cells, the kit prepares a personalized treatment plan for the patient. This allows for better precision and accuracy in treatment, tailored specifically to the patient's needs.
ISO 13485 is the most widely used international standard of the medical equipment industry regarding quality management, which was awarded for the first time to an innovative and knowledge-based product in the field of diagnostic kits.
This international standard, issued by the International Organization for Standardization, ISO, is an effective solution to meet the comprehensive requirements for quality management systems in the medical equipment industry.
Rahbar Andishan Sanat Rad International Company, based in Royan Biotechnology Incubator Center, has supported Kian Immune Cell in establishing a quality management system by international standards.