Hi, we will develop software for a medical instrument that has the potential to cause injuries. The 62604 IEC 2006 standard says "any software that is not developed for the purpose of being incorporated into a medical device" is aSOUP item, and there are heaps of documentations required against aSOUP item, such as functional and performance requirements against the SOUP item.
Has .NET framework, Visual Studio 2012, IIS etc. been validated against medical purpose?