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似水流年在 2023-09-26 14:11 发起了提问 计量校准: 问答检定证书给到的数据如何使用？

你的小可爱: 1-判断设备是否满足检测标准（满足检定规程；不一定满足检测标准；不满足检定规程；不一定不满足检测标准）；2-判断设备是否真的满足检定规程中相应的级别（防止计量部门判断错误）3-发现设备的变化趋势（与以往报告中的数据比较，校准值是否偏离越来越大？越来越不稳定？是否需要采取预防措施？如调试维修或买台新的...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:46 发起了提问 医疗器械技术评审: 问答 If separately registered, do theyhave to clarify the matching situation?

ku1314520: The generator and surgical accessories of high frequencysurgical equipment can either be submitted registration as the wholeproduct, or separately.Hig...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:44 发起了提问 医疗器械技术评审: 问答 the transducer and surgicalinstruments can be connected into other manufacturesmain engine?

ku1314520: The compatibility of main engine, transducer and surgicalinstruments of ultrasound soft tissue surgical equipment will havegreat influence on the prod...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:43 发起了提问 医疗器械技术评审: 问答 what aspects should beconsideredin the application materials?

ku1314520: For large-scale imaging equipment (such as CT,MRPET/CT,etc.), if the third-party physiological gating interface isprovided, such as respiratory gating...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:42 发起了提问 医疗器械技术评审: 问答 Do we need the control groupin the animal experiment?

ku1314520: The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinica...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:40 发起了提问 医疗器械技术评审: 问答 medical X-ray diagnostic equipment ( ClassIII)?

ku1314520: Please refer to the“Guidance for product registrationtechnical review of medical X-ray diagnostic equipment (Class Il ”Clinical parts usually include ...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:38 发起了提问 医疗器械技术评审: 问答 predicate medical device in clinicalevaluation?

ku1314520: Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluati...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:37 发起了提问 医疗器械技术评审: 问答 can we onlycompare the key performances?

ku1314520: Comparison with predicate medical device in clinicalevaluation for active medical device, what content to be comparedis relevant to the product featur...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:36 发起了提问 医疗器械技术评审: 问答 Under what circumstances do environmentatests need to be carried out on medical electricalequipment?

ku1314520: If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if ...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:35 发起了提问 医疗器械技术评审: 问答 When submit Change of Permission Items foradding models, is it necessary for type testing?

ku1314520: First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...; 关注问题 1  0  0 评论

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