Group 1 - The core viewpoint of the article highlights that Angelalign has received the MDR-CE certificate from TV Rheinland, indicating compliance with the EU Medical Device Regulation, which is one of the strictest regulatory frameworks globally [1][3] - The MDR-CE certification signifies that Angelalign's products meet the EU's mandatory legal requirements for safety, effectiveness, and compliance throughout their lifecycle, enhancing international recognition and market credibility [1][3] - CEO Hu Jiezhang emphasized that the certification reflects the company's long-term commitment to product development, quality systems, and compliance capabilities, as well as the rigorous standards set by TV Rheinland [1][3] Group 2 - The certification ceremony took place in Shanghai, with a delegation from TV Rheinland present to officially award the CE certificate to Angelalign [3] - Achieving recognition from an international authority like TV Rheinland marks a significant step for Angelalign in gaining access to high-standard overseas markets [3] - The company has prioritized entering developed markets such as Europe and the US as part of its globalization strategy, necessitating alignment with Western standards in regulatory understanding, data security, product quality, and certification processes [1]
时代天使获TV南德首张隐矫产品欧盟MDR-CE证书 全球化战略再进一步