Quality Management System Overview

SiBionics has established a rigorous Quality Management System in strict accordance with various medical device laws and regulations in addition to ISO 13485, ISO 14971 and other industry standards and best practices. We are applying risk-based thinking to managing the entire product life cycle, adopting PDCA method, always aiming at “zero product defect” and “zero service shortcoming”, and continuously pursuing improvement and excellent performance of the QMS.

Innovation in AI Medical Service QMS

Drawing inspiration from the QMS standards and regulations in the medical device industry, third-party testing centers and other fields, SiBionics has pioneered a unique three-tier quality control system for the AI medical service model, which effectively identifies and manages risks. The in-depth knowledge of company operation allows our quality management team to tailor the system to our specific needs. Through all the efforts, SiBionics is emerging as a champion and pioneer in helping set the quality standards in the medical service sector.