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predicate medical device in clinicalevaluation?

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ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:39

Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluation of medical devices”, thisdifference shall be considered in the comparison.During the comparison, the administrative counterpartsshall describe all the difference related to the software in detailand analyze the influence on the safety and effectiveness of theproducts. If necessary, administrative counterparts shall providethe clinical/non-clinical data of the submitting product itself toprove that the difference has no adverse impact on the safety andeffectiveness.


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发布时间
2023-09-17 22:38
更新时间
2023-09-17 22:39
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