Korea Venture Business Association: "Hexainohill Obtains ISO 13485 Certification"

International Certification for Medical Device Quality Management Systems

The Korea Venture Business Association announced on November 24 that Hexainohill, a medical device company, has obtained ISO 13485 (International Standard for Medical Device Quality Management Systems) certification from ICR, a global medical device certification body.

ISO 13485 is a core certification granted to companies that have established a quality management system meeting international standards throughout the entire process of medical device design, development, manufacturing, and distribution. It is also recognized as a mandatory requirement by major overseas regulatory agencies in the United States, Europe, and Japan.

Through this certification, Hexainohill has strengthened the quality management processes for its main products-the low-level laser-based pain relief medical device 'PainQ' and the rhinitis treatment device 'CobiQ'-to meet international standards. In particular, by fulfilling technical and quality requirements demanded in global markets, such as design verification, risk management, and traceability management, the company has secured a competitive edge in overseas licensing and exports. Hexainohill develops and manufactures various low-level laser-based medical devices in fields such as pain relief and rhinitis treatment.

A representative from Hexainohill stated, "The ISO 13485 certification is an official recognition not only of Hexainohill's technological capabilities but also of the reliability of its manufacturing and quality management systems." The representative added, "With this certification, we plan to further accelerate our entry into global medical device markets in the United States, Europe, and Asia. We will continue to do our utmost to improve quality and ensure product safety going forward."