OTS Verification and Validation of .NET Framework for FDA RRS feed

  • Question

  • I've used the .Net Framework to develop an application which runs on a medical device. I am writing the OTS (Off the shelf) documentation of the .Net Framework for our 510k Premarket Submission for Software Contained in Medical Devices. The FDA guidance pertaining to OTS software is http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073778.htm . There is a section that requires me to "Describe testing, verification and validation of the OTS software and ensure it is appropriate for the device hazards associated with the OTS software. FDA recommends that software test, verification and validation plans identify the exact OTS software (title and version) that is to be used. When the software is tested it should be integrated and tested using the specific OTS software that will be delivered to the user."

    Does anything like this already exist for the .Net framework? I feel like there must be some compliance documentation that I could just reference.
    Wednesday, September 3, 2014 10:33 PM


  • Could you simplified this issue? If you mean .NET Framework Verification, You can refer to :


    • Proposed as answer by Fred Bao Monday, September 15, 2014 7:41 AM
    • Marked as answer by Fred Bao Tuesday, September 16, 2014 9:28 AM
    Friday, September 5, 2014 8:12 AM