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Hello! This is Dongwoo M Techno Co., Ltd., a company built on trust and continuous improvement.
We are pleased to announce the successful completion of our 1st Surveillance Audit for the ISO 13485 Medical Device Quality Management System on September 30, 2025.
This surveillance audit officially confirms that the ISO 13485 system, which we have continuously maintained since 2018, is operating flawlessly in accordance with the latest international standards and our internal operational guidelines.
| Strengthened Quality System Post-GMP Certification |
This audit is particularly significant as it was conducted shortly after we achieved GMP (Good Manufacturing Practice) certification in May 2025.
The ISO 13485 review successfully validated that the new quality management processes and documentation implemented after the GMP achievement have been seamlessly integrated into our existing system. This publicly demonstrates our unwavering operation of a dual, top-tier quality management framework (ISO and GMP).
| Realizing the 'Quality First' Management Philosophy |
Completing the surveillance audit is more than just maintaining a certificate; it is a promise of continued high quality and reliability to the customers and partners who use our products. Based on this robust quality system, we continue to manufacture all our medical supplies, including Sterile Needles and Catheter Cannulas, with the highest levels of safety and efficacy.
Dongwoo M Techno will continue to relentlessly improve and develop its quality management system, growing as a recognized leader in the global medical market.
Thank you.
