What is Cruxi?

Cruxi is a dedicated vertical AI platform tailored for teams engaged in the regulatory landscape of medical devices. It adeptly handles a range of resources, such as FDA regulations, guidance documents, product codes, standards, MAUDE events, recalls, and historical 510(k) submissions, to optimize workflows associated with 510(k), De Novo, and eSTAR applications. Users gain the advantage of swiftly classifying devices, assessing predicates, formulating evidence strategies, and creating thoroughly referenced content that meets eSTAR requirements for every component of their submission. The platform not only facilitates comprehensive submission workflows but also includes specialized micro-services like classification, predicate analysis, and drafting particular sections. This adaptability renders Cruxi especially beneficial for early-stage startups, internal regulatory teams, and consultants, allowing them to generate high-quality submissions while significantly reducing manual labor and minimizing unexpected issues with the FDA. By simplifying the regulatory submission journey, Cruxi ultimately assists organizations in effectively navigating the intricate landscape of compliance and ensuring timely market access for their devices. Consequently, this leads to improved efficiency and increased confidence in regulatory processes.

Pricing

Price Starts At:
Credit-based system

Integrations

No integrations listed.

Screenshots and Video

Cruxi Screenshot 1

Company Facts

Company Name:
Cruxi
Date Founded:
2024
Company Location:
United States
Company Website:
cruxi.ai
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Product Details

Deployment
SaaS
Windows
Training Options
Documentation Hub
Online Training
Support
Standard Support
24 Hour Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Freelance
Nonprofit
Government
Startup
Supported Languages
English

Cruxi Categories and Features

Cruxi Customer Reviews

Write a Review
  • Reviewer Name: Antoine S.
    Position: Regulatory Affairs Consultant
    Has used product for: Less than 6 months
    Uses the product: Monthly
    Org Size (# of Employees): 1,000 - 4,999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    It is a needed product

    Date: Dec 14 2025
    Summary

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

    Positive

    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

    Negative

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

    Read More...
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