07/05/2026
🎉賀！亮宇台北實驗室通過TAF初次評鑑🎉
亮宇台北實驗室正式通過 TAF 初次評鑑，成功取得實驗室認證，象徵在醫療器材檢測能力與品質體系上再創重要里程碑🚀
本次認證範圍涵蓋可提取物與浸出物分析中之半揮發性有機化合物，展現亮宇於化學表徵評估領域的專業實力，並進一步強化對醫療器材風險評估的支援能力。此項成果來自台北實驗團隊的全力投入與高度協作，從文件建置、方法驗證到評鑑執行，皆以嚴謹標準完成，順利取得國家級認可。面對國際法規持續演進，亮宇同步推動技術升級與服務優化，將 ISO 10993 18 化學表徵列為重點發展方向，持續深化可提取物與浸出物分析能力，協助客戶因應全球法規趨勢。
TAF 認證不僅代表對實驗室技術能力與品質管理的肯定，更彰顯亮宇持續邁向國際標準、提升整體服務價值的承諾。未來，亮宇將持續以專業與效率，提供更完整的醫療器材檢測與法規解決方案💪
🎉Congratulations！Leon Biotech Taipei Laboratory Achieves TAF Accreditation🎉
Leon Biotech’s Taipei laboratory has successfully passed the TAF initial assessment and obtained official accreditation, marking a significant milestone in its medical device testing capabilities and quality management system🚀
The accredited scope includes extractables and leachables analysis focusing on semi volatile organic compounds, demonstrating strong expertise in chemical characterization and further strengthening support for medical device risk evaluation. This achievement reflects the dedication and collaboration of the Taipei laboratory team. From documentation preparation and method validation to the on site assessment, every stage was completed with high standards, leading to successful national level recognition. In response to evolving global regulations, Leon Biotech is actively advancing its technical capabilities and service offerings by positioning ISO 10993 18 chemical characterization as a key development focus. This initiative aims to further enhance extractables and leachables analysis capabilities and support clients in meeting international regulatory requirements.
TAF accreditation represents not only recognition of technical competence and quality systems, but also Leon Biotech’s commitment to aligning with global standards and delivering greater value to the medical device industry.
Leon Biotech is here to support your related needs💪
