医疗器械留样管理 Management of Medical Device Sample Retention

gaowenhua

留样量不足：需根据生产规模动态调整，高风险产品建议增加备份样本。
保存条件失控：配置温湿度监控系统，设置报警阈值并定期验证。
追溯链条断裂：采用唯一编码（如 UDI）与生产记录关联，确保可追溯性.




Insufficient sample retention: It needs to be dynamically adjusted according to the production scale, and it is recommended to increase backup samples for high-risk products.
Uncontrolled storage conditions: Configure a temperature and humidity monitoring system, set alarm thresholds, and verify regularly.
Traceability of chain breakage: Use a unique code (such as UDI) to associate with production records to ensure traceability

whyeping

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