On the afternoon of April 25, 2024, in order to continuously advance equipment development and improve product quality, Zhongjiu Flash Medical Technology Co., Ltd. held a special training session on medical device standards and invited the renowned expert, Mr. Sun Zhiyong, to deliver an insightful lecture on the standardization work of medical devices.

Mr.Sun, with his profound accumulation and unique perspective in the field of standardization, elaborated on the importance of standardization work for medical devices, the composition of the standard system, the application of standards at various stages of the industry chain, and the responsibilities and strategies of enterprises in the standardization process. His insights and practical guidelines provided valuable guidance for enterprises to enhance product quality and ensure compliant operations. Mr. Sun currently serves as the Secretary-General of the National Medical X-ray Equipment and Accessories Standardization Sub-Committee, and holds multiple positions such as the national medical device production quality management system inspector, national medical device technical review consultant expert, and expert of the National Artificial Intelligence Medical Device Standardization Working Group. His professional background and contributions to the industry give this lecture high authority and guiding value.

During the meeting, Mr. Sun introduced the content related to the standardization of medical devices from the following aspects:

1. The foundational role of standardization work

Mr. Sun emphasized at the beginning that the standardization work of medical devices is the cornerstone of ensuring product quality and safety. Every link from research and development, procurement, production, inspection to use is closely connected with standards. Standardization work not only plays a key role in quality control throughout the entire life cycle of medical devices but is also a direct reflection of regulatory efficiency. He pointed out that medical device standards are not only the threshold for product market entry but also a guide throughout the entire process from product research and development, production, testing, clinical evaluation to post-marketing management. Compliance with standards means not only meeting regulatory requirements but also whether the enterprise can win the trust of consumers in fierce market competition.

2. Diversity of the standard system and its application

Mr. Sun introduced in detail the classification of medical device standards and their scope of application. The standard system covers four major categories: basic standards, management standards, product standards, and method standards. Basic standards, such as general terminology, provide a common language foundation for the industry; management standards, such as the ISO 9001 quality management system standard, regulate corporate behavior management; product standards, such as GB or YY series, ensure that products meet safety and basic performance requirements at the national or industry level; method standards provide unified procedures and methods for testing performance and safety indicators. He also specifically mentioned the GB9706 series of electrical safety standards and the IEC 60601 series of International Electrotechnical Commission medical device standards, emphasizing the importance of these standards in ensuring the electrical safety, software safety, and network security of medical equipment. At the same time, Mr. Sun reminded enterprises to pay attention to industry development trends, such as the application of artificial intelligence in medical devices, and the new standard requirements that come with it.

3. Deep integration of standards and risk management

Mr. Sun deeply analyzed the role of medical device standards in risk management. He pointed out that standards are not only tools for identifying and controlling risks but also the basis for enterprises to identify risks and design risk control measures. Enterprises should actively identify and apply relevant standards during research and development, procurement, and production processes to ensure that products meet requirements in various aspects such as dosage control and data connectivity. The writing of standards should follow guiding principles, fully consider important performance indicators, and maintain close communication with the team to avoid overly complicated systems. Regarding the relationship between medical device clinical evaluation and standards, Mr. Sun particularly emphasized that clinical evaluation should follow standard specifications to ensure that test methods and comparative data comply with regulations. He also detailed the risk control measures and limitations in medical device standards, emphasizing the dynamic changes and international differences of standards, and how enterprises should respond under this context.

4. Corporate responsibility and cooperation mechanisms

During the meeting, Mr. Sun also emphasized the principal status of enterprises in standardization work, pointing out that enterprises should actively fulfill their responsibilities and establish a good cooperative relationship with testing institutions during the standard implementation process. He reminded enterprises to strictly follow standard requirements in specific situations such as low-altitude environment decoration and equipment testing condition setting to ensure that equipment meets various indicators. Regarding the importance of labeling and instructions, Mr. Sun also pointed out their critical role in risk analysis and user safety, requiring enterprises to ensure their accuracy.

5. Future trends and corporate response

Facing the increasing requirements for medical device standards, Mr. Sun encouraged enterprises to seize the opportunities brought about by technological progress, seek better solutions through technological innovation and research, and actively participate in the standard-setting process. By communicating with the national bureau and technical committees, they can resolve standard conflicts and ensure product compliance. 

After the meeting, the participants generally felt that they had gained a lot, not only having a deeper understanding of the standardization process and risk management of medical devices but also being full of confidence about how to apply this knowledge to their actual work. They actively raised their own questions and opinions and had an in-depth and heated discussion with Mr. Sun.

The successful holding of this training lecture not only improved the professional quality of the participants but also provided them with a platform for learning and communication. They expressed that they hope to have more similar meetings and activities in the future so that they can continue to learn and improve their professional capabilities and level in the field of medical devices. At the same time, they also expressed their heartfelt thanks to Mr. Sun for his professional guidance and looked forward to receiving more guidance and help in their future work.

As a leading company in the field of radiotherapy equipment in China, Zhongjiu Flash will continue to deeply learn about the national policies related to the standardization of medical devices, continuously explore innovation, improve product quality and service level, and better meet the needs of patients.