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Good news! Amison successfully passed iso13485:2016 medical device quality management system certification

Recently, Wuhan amison Life Technology Co., Ltd. (hereinafter referred to as 'amison') successfully passed the SGS (socie é t é g é n é rale de surveillance) ISO13485 medical device quality management system certification and obtained the ISO13485 certificate! This marks that Ameson's quality management system is moving towards a higher level and has laid a solid foundation for Ameson's global commercial layout!

△ ISO13485 certificate

ISO13485 (medical device quality management system requirements for regulation) is the most authoritative international quality system standard in the medical device industry. It is an independent international standard developed by the international organization for Standardization (ISO) and applicable to the medical device industry. It adopts the relevant concept of PDCA based on the ISO9001 standard. Compared with the fact that the ISO9001 standard is applicable to all types of organizations, ISO13485 is more professional and focuses on the organizations in the industries related to the design and development, production, storage and circulation, installation, service, final shutdown and disposal of medical devices. In some cases, it is also one of the export conditions for 'made in China' to enter the international market.


This time, Ameson successfully passed the certification of our 'iso13485:2016' quality management system by the internationally recognized testing, inspection and certification agency SGS, which marks that the company's medical device quality management system has reached a new level, the core competitiveness of products has been enhanced, and the company's global development strategy has taken another key step.

In the future, Ameson will provide more high-quality early tumor detection products and services to more countries and regions in the world, and contribute to human health.


About amison Life Technology

Founded in January 2015, Wuhan amison Life Technology Co., Ltd. is a high-tech enterprise focusing on the R & D, registration, production and sales of early non-invasive detection products for high-risk malignant tumors in the world. The company is committed to the global promotion of cancer early diagnosis technology and products, combining epigenetics, bioinformatics, clinical big data and artificial intelligence analysis, It pioneered and built a new generation of tumor screening and detection technology platform and product system, and took the lead in launching a series of early non-invasive detection products covering digestive system tumors, gynecological tumors, urinary system tumors and pan cancer species. It truly realized early, non-invasive and accurate detection of tumors, fundamentally reduced the incidence rate and mortality of tumors, nipped cancer in the bud, and escorted human life and health.

Focus on the needs of diagnosis and treatment
Take striving innovators as the fundamental


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