On April 15, 2026, Guilin Fukanisen Medical Instrument Co., Ltd. officially passed the ISO13485 Medical Device Quality Management System certification, marking that the company's quality management level has reached international standards, providing a more reliable guarantee for product quality.

Certification Significance

ISO13485 is a standard dedicated to medical device quality management systems issued by the International Organization for Standardization, recognized by major medical device regulatory authorities worldwide. Passing this certification means:

• The company has established a medical device quality management system conforming to international standards
• The entire process of product design, production, and services is effectively controlled
• Product quality and safety are recognized by authoritative institutions
• Lays the foundation for products to enter the international market

Continuous Improvement

Obtaining certification is just the starting point. The company will continue to follow ISO13485 standard requirements, continuously improve the quality management system, enhance product quality, and provide customers with more reliable and safe medical device products.