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ISO13485:2016 was maintained : based on the evaluation from the regular audit.

A regular audit of the quality management system ISO13485:2016 for medical device manufacturer was conducted on October 4, 2024. The auditor evaluated that the system is well established, including in terms of implementation, and that our organization has a high level of commitment and awareness of the quality policy as a whole. We received the audit report and the certification was maintained. We will continue to strive to further improve our quality management system, develop, manufacture and deliver medical devices using cutting-edge technology, and pursue the best solutions for patients.