设备历史记录（DHR）

一个 设备历史记录 (DHR) is a comprehensive documentation that captures the complete history of a medical device’s production, including design, manufacturing processes, quality control measures, and compliance with regulatory standards. It serves as a critical tool for ensuring traceability, accountability, and adherence to industry regulations throughout the 产品生命周期. .通过维护详细的 DHR，企业可以促进有效的审核，提高产品安全性，并支持产品设计和制造实践的持续改进。.