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ku1314520 在 2023-09-17 22:17 回答了问题
is it not applicable to the cybersecurityrequirement?
ku1314520: The applicability of cybersecurity for medical device refersto not only the network connection for electronic data transfer andremote control, but als...
ku1314520 在 2023-09-17 22:16 回答了问题
Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?
ku1314520: The“Guidance for premarket review for medical devicescybersecurity”is applicable to the registration and applicationof Class I and Class Il medical de...
ku1314520 在 2023-09-17 22:15 回答了问题
If the Android APP is registered, isit necessary to be tested when adding iOS APP?
ku1314520: Android and iOS are incompatible operating systemplatforms. To add iOS Apps across platforms, it is necessary to betested with the host, and submit th...
ku1314520 在 2023-09-17 22:13 回答了问题
could the software information in the devicecertificate be updated during Registration Renewal?
ku1314520: Active medical devices and the cooperated softwareare independent medical devices, each with its own registrationcertificate, and the version of the c...
ku1314520 在 2023-09-17 22:12 回答了问题
If medical device software is updated, when willit need to submit Change of Permission Items?
ku1314520: First. manufacture should justify weather the update isconsidered as major update or minor update according to theGuidance for technical review of med...
ku1314520 在 2023-09-17 22:11 回答了问题
How to determine the naming rules for softwareversion?
ku1314520: The software version is used to identify the software statusand to control the software update. The naming rule of softwareversion is decided during t...
ku1314520 在 2023-09-17 22:10 回答了问题
What is software core algorithm?
ku1314520: Software core algorithm refers to the algorithm necessaryto realize the software core function (the function necessary for thesoftware to complete the...
ku1314520 在 2023-09-17 22:07 回答了问题
What should be included in the research data ofactive medical devices service life?
ku1314520: The administrative counterparts shall submit an analysis ancevaluation report on the service life of the product. The report shallspecify the evaluati...
ku1314520 在 2023-08-30 23:09 发起了提问
ku1314520 在 2023-08-30 23:08 发起了提问
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