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标题: 用过CeSub eSubmitter Software的请指教！ [打印本页]

作者: luodaxin2004 时间: 2007-8-22 11:55
标题: 用过CeSub eSubmitter Software的请指教！
哪位大侠使用过CeSub eSubmitter Software,做FDA用的。能具体介绍一下吗？操作复杂吗？

作者: luodaxin2004 时间: 2007-8-23 11:03
怎么看了的人一声都不吭呢？难道没人用？

作者: 火神 时间: 2007-8-23 12:23

引用第1楼luodaxin2004于2007-08-23 11:03发表的 :3 f! k2 g$ V7 a' j* Z
怎么看了的人一声都不吭呢？难道没人用？

这个较少人用的，如果哪位知道的，他一定会勇越解笿的。。。。。

毕竟在论坛不可能什么都知道，请耐心等待高人。。。。。

作者: honseng 时间: 2007-8-23 14:12
CeSub eSubmitter
The Center for Devices and Radiological Health (CDRH) has an electronic submissions program, referred to as CeSub (CDRH electronic Submissions). CeSub evolved as a result of two very successful pilot programs named "eLaser," and "Turbo 510(k)". The CeSub program prepared the next version of the software, a new tool to collect submission data. This new software tool is called CeSub eSubmitter. CeSub eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the device and Radiological Health industries. CeSub eSubmitter is free software that allows sponsors to:

(1) electronically complete and submit premarket notification applications [ 510(k)] to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

(2) electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program.

The CeSub eSubmitter tool includes previously tested features such as the semi-automatic acknowledgement message to the submitter and manufacturer, the Address Book and Contacts Book, PDF files as attachments to the Submission or the Report, the "Missing Data Report," and the ability to save submissions or reports to your hard-drive. There are new features including multiple PDF attachments, improved "Create a Submission" procedure, and more "help" and guidance information. Also, this software is capable of providing automatic updates from the FDA website each time the user opens the application when connected to the Internet. This software application is intended to automate the current paper submission process to the OIVD and The Rad Health Program.

This software contains a number of data capturing tools and helpful dialog boxes to reduce redundant responses from you, and to allow us to capture data in a more useful, structured format. These benefits will improve our review process and reduce lengthy review times at the OIVD and Rad Health Programs. Please feel free to download the software.

作者: luodaxin2004 时间: 2007-8-23 16:45
多谢楼上的解答，不知楼上的是否有操作软件的经验。我目前正在学习使用，不知道这里面的程序怎么这么繁琐？要提交一个报告就这么麻烦？还有数不清的问题要回答！

作者: honseng 时间: 2007-8-24 16:28
因为涉及到安全方面，所有比较繁琐。
刚开始还是耐心点吧！
慢慢熟悉了就没那种感觉了！

如果你已经得到了答案，记得更改主题哦（“已解决”）。

作者: luodaxin2004 时间: 2007-8-24 17:46

引用第5楼sindy于2007-08-24 16:28发表的  :
; g& \3 l* m7 d5 y" y因为涉及到安全方面，所有比较繁琐。
  u( O8 j% v2 P8 X  K9 f刚开始还是耐心点吧！" G' ]4 n; N- G9 r. @  h
慢慢熟悉了就没那种感觉了！: `6 b" q, Y0 `4 B& O2 J3 `+ G+ R8 z
6 {4 U, f( Y! s4 Q3 i4 g1 y! n# p  {
如果你已经得到了答案，记得更改主题哦（“已解决”）。

多谢楼上，以后还请多多指教！我初入行，也是第一次接触这个软件。

作者: titi 时间: 2007-10-15 16:42
我覺得用得很復雜，資料上就比Paper檔的報告多好多，而且有些資料客戶也不愿意提供。

作者: titi 时间: 2007-10-15 16:48
luodaxin2004
有什么心得嗎？

作者: titi 时间: 2007-10-17 10:14
标题: 如何用CeSub eSubmitter Software的ESG提交方式
誰操作過CeSub eSubmitter Software？有人知道用ESG提交報告的操作方式嗎？

作者: honseng 时间: 2007-10-17 10:48
在下址中跟贴讨论吧：
http://www.angui.org/bbs/read.ph ... b%20eSubmitter.html

作者: mumnei 时间: 2010-3-15 13:28
遇到和楼主同样的问题

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