Audience

Medical companies, regulatory consultants

About Cruxi

Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.

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Pricing

Starting Price:
Credit-based system

Integrations

No integrations listed.

Ratings/Reviews - 1 User Review

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 3.0 / 5
More Reviews Write a Review

Company Information

Cruxi
Founded: 2024
United States
cruxi.ai

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Product Details

Platforms Supported
Cloud
Windows
Training
Documentation
Live Online
Support
Phone Support
24/7 Live Support

Cruxi Frequently Asked Questions

Q: What kinds of users and organization types does Cruxi work with?
Q: What languages does Cruxi support in their product?
Q: What kind of support options does Cruxi offer?
Q: What type of training does Cruxi provide?
Q: How much does Cruxi cost?
Q: What pricing for support is available for Cruxi?
Q: What pricing for training is available for Cruxi?

Cruxi Product Features

Cruxi Verified User Reviews

Write a Review
  • Antoine S.
    Regulatory Affairs Consultant
    Used the software for: Less than 6 months
    Frequency of Use: Monthly
    User Role: User
    Company Size: 1,000 - 4,999
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "It is a needed product"

    Posted 2025-12-14

    Pros: The reason for the 5 stars is the fact that the services solved a great pain. I think it is the right use of AI; there is no question to me AI can read predicates and classification docs in minutes what would take a human months

    Cons: It is a do it yourself and you still have to take final decisions on classification and predicate. More guidance would be appreciated

    Overall: I would say a very useful service. It brings a huge added value to the regulatory domain particularly 510k submissions

    Read More...
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