用于医疗设备的.NET 模拟框架
有人有在医疗设备软件中使用 .NET 模拟框架的经验吗？
我目前正在考虑 Moq 和 Rhino Mocks，并希望了解它们在 FDA 和 EU 要求下的使用情况，以及可能为它们中的任何一个进行验证的一些资源。
谢谢！
Does anyone have experience in using a .NET mocking framework for medical device software?
I'm currently considering both Moq and Rhino Mocks and was hoping for some insight on their usage under FDA and EU requirements and possibly some resources on validation performed for either of them.
Thanks!
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根据您的问题，并假设您正在开发一种“受监管的医疗设备”，需要（请参阅 FDA 指南并聘请专家帮助您确定是否适用于您）COTS/工具验证，您已经知道“底线是所有用于构建或测试 FDA 监管软件的第三方工具（和库）需要进行验证。”
参考http:// /rdn-consulting.com/blog/2011/11/12/validation-of-off-the-shelf-software-development-tools/
您对模拟框架的使用可能会陷入上述情况或可能陷入“工具验证”。
您可能希望在这里得到的最佳答案是来自为类似模拟框架做过此类 COTS 或“工具验证”的人的响应。他们也许能够提供“一些建议”，但您不太可能得到他们的 COTS/工具验证计划和记录的验证结果。
最好的建议可能是查看 FDA 指南，并在必要时制定 COTS/工具验证计划，就像您已经为其他开发工具（如编译器、SCM 等）所做的那样。
Based upon your question, and assuming you are developing a "regulated medical device" that requires (see FDA guidance and engage experts to assist you in determining if applies to you) COTS/tool validation, you already know "The bottom line is that all third party tools (and libraries) used to construct or test FDA regulated software need to be validated.".
Reference http://rdn-consulting.com/blog/2011/11/12/validation-of-off-the-shelf-software-development-tools/
Your use of mocking framework could possibly fall into the above or may fall into "tool validation".
The best answer you could probably hope for here would be a response from someone who has done such COTS or "tool validation" for a similar mocking framework. They may be able to provide "some advise", but it is not likely you will get their COTS/tool validation plan and documented validation results.
Best advise is probably to review FDA guidance and if necessary develop a COTS/tool validation plan like you are already doing for your other development tools such as compilers, SCM, and so on.