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Status Unreviewed
Created by Guest
Created on Jan 5, 2022

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.

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  • Guest
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    Jan 10, 2022

    Here is a blog article that talks more about the requirement

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