From December 10, 2018 to December 11, 2018, the audit experts of Nande Certification & testing (China) Co., Ltd. came to our company to conduct a comprehensive inspection of the company's quality management system, and have now successfully passed the certificate renewal audit!
The expert group reviewed the operation of our company's human resources, upgraded quality management documents, production process, quality control, procurement and sales systems, and focused on the design and development of foam dressings, disposable medical aseptic applications, etc. Special process confirmation and other links. At present, the supervision of medical devices has been strengthened, and a series of laws, regulations and working papers have been issued. On May 5, 2017, the European Union officially issued a new law on medical devices, (Medical Devices Regulation, Regulation (EU) 17 / 745). The new regulation expands the scope of regulatory products, strengthens the supervision of clinical evaluation and clinical evidence, and improves the protection mechanism for patients. Our company will continue to study the new MDR regulations, constantly improve, improve quality management system, improve compliance with the regulations.