In order to implement the long-term development strategy of “base the domestic market and develop the global market", relying on professional R&D team, precision manufacturing engineers and quality and regulatory management team, EndoSystem Medical continuously achieve the richness and innovation of product pipeline, and strictly follow the relevant domestic and international regulatory requirements in the process of product design and development, manufacturing and distribution. At this stage, EndoSystem Medical's domestic product registration and international certification have achieved certain results.
At present, EndoSystem Medical has obtained 2 Class III product registration certificates, 5 Class II product registration certificate, 1 Class I product registration certificate and the first registration certificate under the registered holder system in Hubei Province. And CE certification of several endoscopic surgical products are under application.
Recently, EndoSystem has obtained the ISO 13485 medical device quality management system certification, which was issued by the authority notified body BSI(British Standards Institution). The approval of ISO 13485 certification not only affirms EndoSystem Medical's existing quality management system and product quality, as well as the company's minimally invasive surgical device product design and development, manufacturing and distribution process in full compliance with international quality standards, but also It has laid a qualification foundation for EndoSystem Medical to enter the international market in the near future, and is an important milestone in the company's product development, registration and international certification.
The full name of ISO 13485 is "Requirements for Medical Device Quality Management System for Regulations", which is an independent international standard formulated by the International Organization for Standardization (ISO) and applicable to the medical device industry.The ISO1 3485 certification standard focuses on medical device regulations, emphasizes the importance of implementing medical device regulations, puts forward relevant medical device regulations, and ensures the safety and effectiveness of medical devices by meeting the requirements of medical device regulations.
Enterprises certify products according to the ISO 13485:2016 standard, enabling manufacturers to prove whether the medical devices and services they provide meet market standards and applicable regulatory requirements, and provide a practical tool for solving product consistency assessment processes. At the same time, it demonstrates a company's commitment to medical device quality and safety.
In the future, EndoSystem Medical will continue to adhere to the management requirements of the ISO 13485 system and strictly follow domestic and international laws and regulations, and fully promote the long-term development strategy, and is committed to providing safe, effective and high-quality products to the global market, providing patients with more advanced surgical treatment solutions and contributing to the cause of human health and creating value.