Hunan Runmei Gene Technology Co., Ltd. announced on June 24, 2020 that the quality management system (QMS) for the medical device industry has been certified by the International Organization for Standardization (ISO) quality standard 13485:2016, and won unanimous praise from customers and certification bodies.
ISO 13485 is the internationally recognized highest quality standard for medical industry organizations. A completely independent standard dedicated to the medical device industry , based on the ISO9001 "Quality Management System Requirements" standard. The ISO13485 certification standard is based on medical device regulations, emphasizing the importance of implementing medical device regulations, proposing relevant medical device regulations, and ensuring the safety and effectiveness of medical devices by meeting the requirements of medical device regulations. By obtaining this certification, Hunan Runmei Gene Technology Co., Ltd. ranks among the powerful ISO 13485 medical certification factories.
Hunan Runmei Gene Technology Co., Ltd. builds a well-known brand in China's big health industry with its honest and pragmatic style and spirit of reform and innovation. "Survival by quality, development by innovation; win market by speed, build brand by service" is the company's quality policy. Its subordinate factories have already possessed advanced production process, perfect quality assurance system, and obtained ISO13485 certification. All of its products have been certified by the European Union CE, and some of the products have been certified by the US FDA, and have entered the list of medical material manufacturers that have obtained foreign standard certification or registration confirmed by the Ministry of Commerce. Such as Single-use samplers, Virus Nucleic Acid Extraction Kit or Nucleic Acid Detection Kit, New Coronavirus COVID-19 Nucleic Acid Detection Kit(Fluorescent RT-PCR Method), New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold), etc. are exported to the United States, Germany, the United Kingdom, Spain, Italy, the Netherlands, Japan, South America, the Middle East, Southeast Asia and other countries and regions ,and well received by consumers from various countries.
