Cruxi
Description:
Cruxi is an AI-powered regulatory submission platform for medical device teams that automates FDA 510(k), De Novo, PMA, IDE and global filings by using AI-driven device classification, predicate finding, eSTAR drafting, automated RTA/compliance checks, evidence planning and package export combined with human-in-the-loop review; its models are trained on FDA guidance and regulatory databases with traceable citations (zero-hallucination claims), continuous regulatory updates, and enterprise-grade security to help teams move faster, reduce refusal-to-accept risks, and produce reviewer-ready, submission-quality dossiers.
A platform for regulatory submissions of medical devices with compliance checks and human review.
Note: This is a Google Colab, meaning that it's not actually a software as a service. Instead it's a series of pre-created codes that you can run without needing to understand how to code.
Note: This is a GitHub repository, meaning that it is code that someone created and made publicly available for anyone to use. These tools could require some knowledge of coding.
Pricing Model:
Paid
Price Unknown / Product Not Launched Yet
This tool offers a free trial!
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Matt's Pick - This tool was selected as one of Matt's Picks!
Note: Matt's picks are tools that Matt Wolfe has personally reviewed in depth and found it to be either best in class or groundbreaking. This does not mean that there aren't better tools available or that the alternatives are worse. It means that either Matt hasn't reviewed the other tools yet or that this was his favorite among similar tools.
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Cruxi
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A platform for regulatory submissions of medical devices with compliance checks and human review.
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