Core Insights - Angelalign Biotechnology Co., Ltd. has received the MDR-CE certification, marking a significant step in meeting EU medical device regulations and enhancing its market credibility [1][2] Group 1: Certification and Compliance - The MDR-CE certificate was awarded by T V Süddeutsche Group, a globally recognized Notified Body in medical device certification, indicating that Angelalign's products meet stringent EU safety, efficacy, and compliance standards [1] - The certification process involved rigorous multi-dimensional reviews of product technology, clinical evaluation, quality management systems, and post-market surveillance, reflecting the high standards of the EU's Medical Device Regulation (MDR) [1] Group 2: Strategic Positioning - The CEO of Angelalign emphasized that the CE certification is a result of the company's long-term investment in product development, quality systems, and compliance capabilities, alongside the strict requirements set by T V Süddeutsche [2] - Since initiating its globalization strategy, Angelalign has prioritized entry into developed markets such as Europe and the U.S., necessitating alignment with the highest regulatory standards and local medical practices [2]
时代天使获T V南德首张隐矫产品欧盟MDR-CE证书 全球化战略再进一步