Cruxi Description

Cruxi is a specialized vertical AI platform designed for teams involved in the regulatory processes of medical devices. It efficiently processes a variety of sources, including FDA regulations, guidance documents, product codes, standards, MAUDE events, recalls, and historical 510(k) submissions to enhance workflows related to 510(k), De Novo, and eSTAR applications. Users benefit from the ability to quickly classify devices, analyze predicates, strategize evidence presentation, and create fully referenced content that aligns with the requirements of eSTAR for each part of their submission. The platform not only provides comprehensive submission workflows but also offers targeted micro-services, such as classification, predicate evaluation, and drafting of specific sections. This versatility makes Cruxi particularly valuable for early-stage startups, in-house regulatory teams, and consultants, enabling them to produce high-quality submissions while minimizing manual effort and reducing unforeseen challenges with the FDA. By streamlining the regulatory submission process, Cruxi ultimately helps organizations navigate the complexities of compliance more effectively.

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Pricing

Pricing Starts At:
Credit-based system

Integrations

No Integrations at this time

Reviews - 1 Verified Review

Total
ease
features
design
support
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Company Details

Company:
Cruxi
Year Founded:
2024
Headquarters:
United States
Website:
cruxi.ai
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Media

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Product Details

Platforms
Web-Based
Windows
Types of Training
Training Docs
Live Training (Online)
Customer Support
Business Hours
Live Rep (24/7)

Cruxi Features and Options

Cruxi User Reviews

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  • Name: Antoine S.
    Job Title: Regulatory Affairs Consultant
    Length of product use: Less than 6 months
    Used How Often?: Monthly
    Role: User
    Organization Size: 1,000 - 4,999
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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

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