Day: 9 5 月, 2024

前 FDA 审查员：如何避免 STeP 中的失误、突破性设备提交

医疗器械专家在 2024 年 RAPS 全球监管战略会议上讨论了如何为 FDA 的突破性器械计划和安全技术计划（STeP）提交材料，以及如何回应缺陷信。

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