上市后监管要求

Ambati Keerthana
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引用次数: 0

摘要

PMS可以是用于筛选医疗设备执行的表单和活动的集合。概述这些活动是为了创建关于小工具使用的数据,以方便地区分小工具计划和/或使用问题,并精确地表征现实世界的设备行为和临床结果。对PMS的需求在设备商业化后迅速出现。在项目改进过程中,确保对危害管理处理的满意的恢复性输入将有助于生产者描述可想象的项目安全问题。
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Requirements of Post Market Surveillance
PMS may be a collection of forms and activities utilized to screen the execution of a medical device. These activities are outlined to create data with respect to utilize of the gadget to expediently distinguish gadget plan and/or utilization issues and precisely characterize the real-world device conduct and clinical results. The require for PMS emerges promptly upon commercialization of the device. Ensuring satisfactory restorative input into the hazard administration handle amid item improvement will offer assistance producers characterize conceivable item safety issues.
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