医疗器械

Medical devices are instruments, apparatuses, or machines designed for medical purposes, including diagnosis, prevention, monitoring, treatment, or alleviation of disease. They range from simple tools like bandages to complex technologies such as MRI machines, and their development involves rigorous research and adherence to regulatory standards to ensure safety and efficacy. In product design and innovation, medical devices must integrate 以用户为中心 design principles to enhance usability and improve patient outcomes.

.医疗器械标准完整框架。ISO 13485

医疗设备标准完整框架

除了常见的医疗器械全球标准和规范外,还包括ISO 13485:医疗器械--质量管理体系--对医疗器械的要求

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