FDA法规-IDE的独立验证 [英] FDA regulations - independent validation of the IDE

问题描述

我正在尝试完全理解本文，对此我有几个问题.

I'm trying to fully understand this article, and I have several questions about it.

https://msdn.microsoft.com/zh-CN/library/hh134108(v = vs.100).aspx#bkmk_validation

https://msdn.microsoft.com/en-us/library/hh134108(v=vs.100).aspx#bkmk_validation

首先，我感谢尝试展示Visual Studio 2010工具如何帮助人们满足法规要求的尝试，但是我的理解是该工具本身必须以某种方式进行验证.那篇文章没有解决这个问题.我很好奇 为什么Microsoft专门为Visual Studio 2010提供该文章.在以后的版本中，我看不到类似的文章.  

First, I appreciate the attempt to show how Visual Studio 2010 tools can help one meet regulatory requirements, but my understanding is that the tool itself has to be validated in some way.  That article doesn't address that.  I'm curious about why Microsoft provided that article specifically for Visual Studio 2010.  I don't see a similar article under future versions.  

本文还没有100％清楚说明Microsoft与Northwest Cadence之间的关系.微软是否专门要求Northwest Cadence验证IDE功能，以便开发医疗设备软件的公司不要 必须独立认证此IDE?尽管可以从概念上了解该工具将如何在法规遵从性的其他方面提供帮助，但我仍然看不到如何满足对工具本身进行验证的要求.而且，稍后 版本的Visual Studio似乎都具有相同的功能以及更多功能.因此，我认为这些版本也将有助于满足所有这些法规要求.

The article also doesn't make it 100% clear what the relationship is between Microsoft and Northwest Cadence.  Did Microsoft ask Northwest Cadence specifically to validate the IDE capabilities so that companies developing medical device software don't have to independently certify this IDE?  Although I can see conceptually how the tools would help with other aspects of regulatory compliance, I still don't see how the requirement for the validation of the tool itself has been met.  Moreover, later versions of visual studio all seem to have the same capabilities plus more.  Therefore I would think that those versions would help meet all of those regulatory requirements just as well.

对我来说，最重要的事情是，通过证明这些功能确实有效，知道是否向Northwest Cadence支付了我的Microsoft费用，以证明其符合FDA法规的IDE.换句话说，该技术文章有什么用 对于开发医疗设备软件的公司来说确实意味着.该工具可以完成所有这些事情仅仅是一种销售推销，还是使用VS2010的公司可以将IDE进行第三方认证的结果?

The thing that is most important to me is knowing whether Northwest Cadence was paid my Microsoft to certify their IDE for meeting FDA regulations by demonstrating that these features actually work.  In other words, what does that technical article really mean for companies developing medical device software.  Is it just more of a sales pitch that the tool can do all of these things, or is it truly the result of a 3rd party validation of the IDE that companies using VS2010 can point to as evidence that the tool is certified for use for meeting FDA regulations?

推荐答案

嗨肖恩，

据我了解，VS2010本身已经过验证，Northwest Cadence是Microsoft合作伙伴.

As my understanding, VS2010 itself has been validated and Northwest Cadence is Microsoft Partner.

您对"Northem Cadence支付我的Microsoft费用以表明他们可以通过FDA证明其符合FDA法规"表示什么意思??我无法完全理解此含义，请描述您的问题 更详细.

what's your mean about "Northwest Cadence was paid my Microsoft to certify their IDE for meeting FDA regulations by demonstrating that these features actually work"? I could not fully understand this meaning, please describe your issue in more detail.

此致

奥斯卡

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