Is .NET framework certified/validated against 62304 IEC 2006 - Medical Device Software Development Standard? RRS feed

  • Question

  • 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 a SOUP item, and there are heaps of documentations required against a SOUP item, such as functional and performance requirements against the SOUP item.

    Has .NET framework, Visual Studio 2012, IIS etc. been validated against medical purpose?

    Monday, September 23, 2013 6:22 AM


  • Hi,

    I would advice you to contact Microsoft directly instead of asking the fellow forum members. Forum members would give you their own personal opinion but Microsoft support would give you the answers you're looking for.

    Regards, Pa445

    Monday, September 23, 2013 2:26 PM