Quality System

We take pride in the quality of each of our products,
reflecting the most up-to-date safety standards.

Our advanced quality management system has served to win the unshakeable trust of customers. Because our products come into direct contact with the human body, safety is an absolute top priority. Our quality management system has the strict standard, so advanced that it warrants the label the"Fuji Systems Standard". This standard is stricter than many standards for medical device, as well as standards required by the various fields of the medical treatment.

Our quality management system is approved for many quality standards and regulations, such as ISO 13485:2016, MDD(Medical Device Directives), and MDSAP (Medical Devices Single Audit Program). This array of certifications means that Fuji Systems is recognized as a medical-device manufacturer endowed with quality assurance systems that cleared international standards.

ISO13485:2016ISO13485:2016
CE77043CE 77043
CE55009CE 550009