ExaBio Innovations has now passed the ISO 13485:2016 Medical Device Quality Management System certification
10月 9, 2026
ISO 13485 is a globally recognized authoritative quality standard in the medical device industry, covering risk management, design and development, precision manufacturing, testing and validation, and delivery management throughout the entire product lifecycle. Relying on its own film/mold factory, CNC micro/nano processing, precision mold system, and self-developed glass bonding process, Yisheng Medical Innovation will implement standardized quality control in the research and production of microfluidic biochips, including low fluorescence background film chips, COC/COP optical chips, digital PCR chips, chemotaxis chips, and other precision microfluidic devices.
The acquisition of certification signifies our ability to deliver stable and compliant medical device components and microfluidic consumables, which can support our customers' IVD localization projects and better meet the strict regulations and quality requirements in the fields of medical diagnosis and life sciences at home and abroad. We continue to ensure microstructure accuracy, material traceability, and batch consistency with a rigorous quality system, providing global partners with one-stop microfluidic chip manufacturing services from prototype sampling, rapid validation to large-scale production.
