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bombsy's avatar
bombsy
New Contributor
5 years ago
Solved

software tool validation for Medical Devices

Hello All,

I need to do TC software tool validation for the Medical Devices with the FDA/MRD standards [following regulation of: 21 CFR 820.70(i)] - looking for the example from someone who has done something similar or can share some opinions.

Thanks in advance and have a good day 🙂

Cheers, Bombsy.

Medical devices
  • AlexKaras's avatar
    AlexKaras
    5 years ago

    Hi Bombsy,

     

    > Ill get back to you soon.

    Don't get me wrong please, but I am afraid that I will not be able to be of much help here. Instead, I would recommend to contact Sales or Support via the https://support.smartbear.com/message/?prod=TestComplete form and hopefully guys will provide you with more relevant info.

     

4 Replies

    • bombsy's avatar
      bombsy
      New Contributor
      5 years ago

      Hello Alex,

      Thank you for yuor quick replay - let me get familiar with this and Ill get back to you soon.

      Have a good day,

      Bombsy.

      • AlexKaras's avatar
        AlexKaras
        Community Hero
        5 years ago

        Hi Bombsy,

         

        > Ill get back to you soon.

        Don't get me wrong please, but I am afraid that I will not be able to be of much help here. Instead, I would recommend to contact Sales or Support via the https://support.smartbear.com/message/?prod=TestComplete form and hopefully guys will provide you with more relevant info.

         

  • rrivest's avatar
    rrivest
    Contributor
    5 years ago

    Hi Bombsy....

     

    What is not clear in your question is what you want to validate under the FDA regulations... Is it an an imbedded software on a medical device the medical device itself or the testing tool itself ?  Is it relevant to HIPPA regulations ? The tool is just a tool... How you build the automation depends  on you target... if there are confidentiality aspects, it's a matter of framework, the tool itself is irrelevant...  

     

    Please clarify the purpose and what you are looking for... The tool itself will not test a device against FDA regulations... it<s the testcase you build that will do such thing...