Recently, Cygnus Biosciences (Beijing) Co., Ltd. successfully passed the TÜV Rheinland ISO 13485 audit for medical device quality management systems and obtained the certification. This marks that the quality management system of Cygnus Bio meets international requirements.
Developed by the International Organization for Standardization (ISO), ISO 13485 is the most authoritative international quality system standard for the medical device industry. The standard is legally binding and operates within a regulatory environment, imposing stricter and higher requirements for quality management practices in the design, development, production, and customer service of medical devices.
Cygnus Bio's achievement of ISO 13485 certification is inseparable from the high‑standard quality management system established throughout its production processes. Since its founding, Cygnus Bio has adhered to the quality management policy of "integrity and trustworthiness, quality first, continuous innovation, and lean practice." The company has built a rigorous enterprise‑level quality management system and continuously upgrades and optimizes its quality management methods and capabilities through the introduction of new technologies and management approaches. This has resulted in a professional and evolving quality management system that consistently supports the production of its Sequencing System products.
Cygnus Bio was founded by the team of Professor Sunney Xie, Professor Yanyi Huang, and Dr. Zitian Chen from Peking University. As a national high‑tech enterprise integrating research, development, transformation, production, and marketing of gene sequencing instruments, Cygnus Bio has launched its first product, the GS100 Sequencing System, based on two core gene sequencing technologies with wholly independent intellectual property rights: fluorogenic chemistry and error‑correcting code (ECC)‑based sequencing. Looking ahead, while continuing to optimize its benchtop product series, Cygnus Bio will introduce new gene sequencer product lines designed for centralized clinical testing needs and even simpler, more intelligent operation. These efforts aim to meet the demands of increasingly complex research and clinical scenarios, provide life sciences with more precise research tools, and offer a more comprehensive testing platform for medical and health applications.
