Hexanohill Obtains ISO 13485 Certification, the International Standard for Medical Device Quality Management.

Hexanohill announced on the 24th that it had obtained ISO 13485 certification, the international standard for medical device quality management systems, from ICR, a global medical device certification agency.

ISO 13485 is a core certification granted when the entire process of medical device design, development, manufacturing, and distribution conforms to international standards, and is recognized as a mandatory requirement by major overseas regulatory agencies in the U.S., Europe, and Japan.

With this certification, Hexanoheal has strengthened its quality management system for its low-power laser-based pain relief medical device, "PainQ," and its rhinitis treatment device, "CobiQ," to international standards. By meeting quality and technical requirements demanded in the global market, including design verification, risk management, and traceability, Hexanoheal is expected to strengthen its competitiveness in securing overseas approvals and exports.

A company representative stated that ISO 13485 certification officially recognizes not only the company's technological prowess but also the reliability of its manufacturing and quality management system. The company plans to further accelerate its entry into global medical device markets, including the US, Europe, and Asia, based on this certification. The company also announced its commitment to continuously improving quality and ensuring product safety.