In recent years,China's medical device industry has been developing rapidly,with digital transformation emerging as an important means to promote high-quality development.The level of digitalization in the industry has steadily improved,and the swift progress of industrial digitalization has accelerated the development of digital supervision,offering new approaches to enhance supervisory efficiency.Several regions in China have initiated pilot programs for intelligent supervision,yielding initial positive results.However,challenges remain for industrial digitalization:enterprises face high costs for digital transformation,significant disparities exist in the digital transformation processes of enterprises of different scales,and there are difficulties in promoting industrial digitalization.Similarly,in terms of digital supervision,there is a lack of effective planning and unified design,widespread redundancy in platform construction,and low efficiency in collaborative supervision.This article focuses on the digital transformation of the medical device manufacturing stage and digital supervision,explores technical solutions for the digital transformation of both enterprises and regulatory authorities.It also puts forward suggestions for promoting the continuous improvement of digital intelligence in medical device manufacturing stage and the level of digital supervision.
关键词
医疗器械/生产环节/新型信息技术/数字化转型/数字化监管
Key words
medical devices/manufacturing stage/novel information technology/digital transformation/digital supervision
维普
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