The Success of Knowledge based company in Royan Institute in Obtaining the ISO 13485:2016 International Certificate
The international standard certificate 2016: ISO 13485 has been granted to a knowledge-based product called "Chemobiogram Kit" by the ISO international standard organization. Kian immune cell Knowledge-based Company, which is one of the companies based in Royan Research Institute, was successful in obtaining this certificate.
According to scientific findings, one of the issues facing cancer patients is the emergence of drug resistance following therapy, and the presence of treatment-resistant cells is the primary factor in these patients' failure to respond to chemotherapy and radiation therapy. Before prescribing a medication, the doctor can utilize a "chemobiogram kit" to determine the optimal drug combination to which the patient is sensitive. The optimal medicine combination for the patient is created in this kit utilizing the patient's own tumor cells, opening the door to individualized treatment.
The most generally applied international standard for the medical equipment sector is about quality management, and it has for the first time been given to a cutting-edge and knowledge-based diagnostic kit product. The International Organization for Standardization, ISO, has produced this international standard as a practical means of satisfying the stringent requirements for quality management systems in the medical equipment sector. Kian Immune Cell has been followed on this journey by Rahbar Andishan Sanat Rad International Company, as a consultant for the establishment of a quality management system in compliance with international standards.
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