Practice and Prospect of Group Standard for Innovation and Transformation of Medical Equipment

Abstract

The importance of group standards is becoming increasingly evident. These standards are developed and released by groups following their own established procedures, intended for voluntary adoption by group members or the public. In the field of medical equipment innovation and transformation, group standards play a crucial role in multiple aspects. They provide unified technical specifications and operational procedures, clearly defining quality requirements and evaluation criteria at each stage, which helps reduce the randomness in R&D and enhances the efficiency of transformation. They also facilitate communication and collaboration among industry, academia, research, and application sectors, enabling scientific research institutions, medical facilities, and enterprises to share resources and complement each other’s strengths within a common standard framework, thus accelerating the transition of innovative outcomes from the laboratory to the market. By establishing group standards, the healthy development of the industry can be guided, market order can be standardized, and the overall quality and international competitiveness of China’s medical equipment products can be enhanced, promoting China’s transition from a major player to a leader in medical equipment manufacturing. Through an in-depth exploration of the practical applications and development trends of group standards in the innovation and transformation of medical equipment, researchers can better understand the intrinsic connections and mechanisms between group standards and the innovation and transformation of medical equipment, providing new perspectives and theoretical foundations for future research, and enriching the theoretical framework in this field.