Skip to Main Content

FDA Software Validation Test Case

Related to the general validation principles Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. The client would need document stating the notes and testing information on each Absorb release, then the client would go through and complete a vendor audit and complete the test cases to validate any concerns related to the release.

  • Attach files
      Drop here to upload
    • Admin
      David Ferrucho
      Reply
      |
      Feb 27, 2025

      Thank you for sharing your idea. After careful consideration, we’ve determined that we are unable to prioritize this suggestion at this time. While we appreciate the value of your request, our current roadmap commitments and resource constraints prevent us from pursuing it in the near future.

      However, your idea remains in our repository, and we will revisit it as we continue evaluating improvements to the LMS, including the integration of FDA software validation.

      Your feedback is invaluable in shaping our platform, and we truly appreciate your contribution.

    • Guest
      Reply
      |
      Jan 10, 2022

      Here is a blog article that talks more about the requirement

      https://www.datacor.com/the-datacor-blog/fda-software-validation