Recently, EndoSystem Medical has successfully obtained the first CE certificate in compliance with the EU Medical Device Regulation (Regulation (EU)2017/745,referred to as MDR). This achievement signifies that EndoSystem Medical is the first manufacturer to obtain the CE-MDR certificate for the automatic ligating clip applier (polymer clips) in China.
The attainment of this certification is a testament to EndoSystem Medical's unwavering commitment to excellence and innovation in the medical device industry. With this certification, the automatic ligating clip applier can now be marketed and sold throughout the EU, offering surgeons a more reliable and efficient method for ligating tissues during laparoscopic surgical procedures that enhances surgical outcomes and patient safety.
The journey to obatain the CE-MDR certificate was no small feat. It involved a rigorous process of evaluation and compliance checks to ensure that the product met the highest standards of safety, performance, and quality. EndoSystem Medical's dedicated team worked tirelessly to align their manufacturing processes, quality management systems, and clinical evaluation strategies with the new regulation's requirements.
As celebrating this significant achievement, EndoSystem Medical remains dedicated to its mission of advancing medical technology and contributing to the global healthcare community. The CE-MDR certification is a proud moment for EndoSystem Medical, marking a new chapter of growth and success in our ongoing commitment to excellence.