From July 2nd to 4th, 2025, Mr. Xiang and Ms. Cai from Intertek conducted a three-day rigorous audit of Tiankang Medical Technology Co., Ltd. The audit covered three important systems: MDR CE, ISO13485, and MDSAP. This audit is of great significance, aiming to comprehensively evaluate Tiankang Medical's performance in medical device quality management, regulatory compliance, etc., and provide strong support for the company to continuously improve product quality and service levels.​

As an important enterprise in the industry, Tiankang Medical Technology Co., Ltd. has been committed to the research, development and production of various medical consumables such as disposable syringes and infusion sets. Since its establishment, the company has always adhered to the principle of "adhering to quality to prosper the enterprise and safeguarding human safety", and attached great importance to the construction and improvement of the quality management system.​

The MDR CE certification is a strict regulation formulated by the European Union for medical devices, aiming to ensure the safety and effectiveness of medical devices and protect the health and safety of patients and users. ISO13485 is an internationally recognized standard for medical device quality management systems, providing a standardized guidance framework for the entire process of medical device design, development, production, installation and service, emphasizing meeting customer and regulatory requirements and continuously improving product and service quality. MDSAP integrates the regulatory requirements of multiple countries and regions, covering the quality system requirements of multiple markets through a single audit, which greatly improves audit efficiency and reduces the compliance costs of enterprises.​

During the three-day audit, Mr. Xiang and Ms. Cai conducted a meticulous review of various aspects of Tiankang Medical, including quality management system documents, design and development processes, production process control, supplier management, product inspection and monitoring, and after-sales service, in strict accordance with relevant standards and regulations. They gained a comprehensive and in-depth understanding of the company's operations through various methods such as reviewing document records, on-site observation, and communicating with employees. During the audit, the auditors fully affirmed Tiankang Medical's many efforts in quality management.​

At the same time, the auditors also put forward some valuable suggestions for improvement. In terms of risk management, it is suggested that the company further improve the risk assessment process, identify potential risks more comprehensively, and formulate targeted response measures; in terms of internal communication mechanisms, it is necessary to strengthen information sharing and collaboration between different departments to improve work efficiency. The management and relevant department heads of Tiankang Medical attached great importance to the suggestions put forward by the auditors, stating that they will immediately formulate a detailed rectification plan, actively implement improvement measures, and ensure the continuous optimization and upgrading of the company's quality management system.​

The successful completion of this audit is not only a comprehensive test of Tiankang Medical's past efforts in the construction of the quality management system, but also points out the direction for the company's future development. By meeting the strict requirements of MDR CE, ISO13485 and MDSAP, Tiankang Medical will further enhance its competitiveness in the international market, provide more high-quality, safe and reliable medical device products for global customers, and make greater contributions to the cause of safeguarding human health. It is believed that with the joint efforts of all employees of the company, Tiankang Medical Technology Co., Ltd. will surely achieve more brilliant achievements in the field of medical devices.