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Productivity & writingDocumented overviewLast checked Sep 29, 2026

Cruxi: Pricing, Features & Best Use Cases

AI-assisted platform for FDA 510(k) and other regulatory submissions, plus consultant and provider directories.

Cruxi homepage screenshot, productivity & writing AI tool

Our take: Cruxi suits medical device startups and regulatory teams preparing FDA 510(k) and related submissions, but current pricing is not published.

Main limitation: The pricing page returns 404 and earlier launch promo prices have expired, so cost is unknown; claims like zero hallucinations are not independently verified.

By the AI Tool Atlas editors. Based on the vendor's official documentation; we have not tested this product hands-on. What “documented overview” means

Is Cruxi right for you?

Cruxi suits medical device startups and regulatory teams preparing FDA 510(k) and related submissions, but current pricing is not published. Based on the vendor's documentation, not on a hands-on test.

Best for: Medical device startups

Also a good fit for

  • Regulatory affairs teams preparing FDA submissions
  • Companies looking for 510(k) consultants or regulatory service providers

Consider another tool if homepage prices are launch promos that end May 21, 2026

Or if

  • /pricing page returned 404
  • Marketing claims such as zero hallucinations are not independently verified

Cruxi pricing and usage limits

Prices checked Sep 29, 2026 on the official US pricing page. Prices and limits change often.

Free access and trial conditions

Start Free with no card required per homepage.

Not stated.

Paid plans: what changes as you upgrade

Free start web

Free source (opens in a new tab)

Month

Homepage advertises Start Free with no card; limits not stated.

For: Trying the platform

Usage caps, credits and extra costs

Promo prices on the homepage expired May 21, 2026 per the site; current prices unknown.

Not stated.

What is Cruxi, and how does it work?

Cruxi offers AI-powered workflows for medical device regulatory submissions, including FDA 510(k), De Novo, Pre-Sub and several global pathways, with compliance checks and optional expert review. It also runs directories of 510(k) consultants and regulatory service providers where users can compare and request quotes.

Cruxi homepage — screenshot of the productivity & writing AI tool, Oct 2, 2026
Cruxi's official site: how the product presents itself. cruxi.ai, captured Oct 2, 2026

What you provide and what you get back

How Cruxi works: what you provide, where it runs and what you get backYOU PROVIDEYour inputDevice informationRegulatory documentsStudy dataPRODUCTIVITY & WRITINGCruxiWebfree tier, paid price not publish…free tier availableaccount requiredchecked Sep 29, 2026YOU GET BACKThe resultSubmission documentsCompliance and RTA check resultsExportable submission packagesinput → Cruxi → output · from the vendor's own pages, no hands-on test unless stated
What you give Cruxi and what comes back, from its documentation

You provide

  • Device information
  • Regulatory documents
  • Study data

You get back

  • Submission documents
  • Compliance and RTA check results
  • Exportable submission packages

Where you can use it

Platforms
Web
Account
Required
Services
14 (FDA and global)
FDA pathways
510(k), De Novo, Pre-Sub, 513(g), PMA supplements
Global
EU MDR, UKCA, Health Canada
Checks
RTA and compliance

What people use Cruxi for

Scenarios are worked out by our editors from the documentation; the actual result depends on your input and plan.

Prepare a 510(k) submission

Who
Medical device startups
You provide
Device description and classification
Expected result
A drafted 510(k) workflow and submission package
Plan needed
Free start
Limitation
Pricing unknown source (opens in a new tab)

Draft a De Novo request

Who
Regulatory affairs teams
You provide
Novel device details
Expected result
A De Novo request draft
Plan needed
Not stated
Limitation
Review needed by experts source (opens in a new tab)

Find a 510(k) consultant

Who
Device companies
You provide
Submission needs
Expected result
Consultants and providers from directories with quote requests
Plan needed
Free directories
Limitation
Provider quality not verified source (opens in a new tab)

Key features and their practical limits

Cruxi homepage — screenshot of the productivity & writing AI tool, Oct 2, 2026
Feature overview on the official site. cruxi.ai, captured Oct 2, 2026

14 regulatory services

Covers 14 regulatory services across FDA and global pathways such as 510(k), De Novo, PMA supplements and EU MDR. Handles many submission types in one place.

Access: PlatformLimit: Service depth not captured source (opens in a new tab)

Automated compliance and RTA checks

Runs automated compliance and RTA checks on submissions. Catches gaps early.

Access: PlatformLimit: Vendor claims not verified source (opens in a new tab)

Document management

Manages documents for submissions. Keeps files organized.

Access: PlatformLimit: Details not captured source (opens in a new tab)

Export of submission packages

Exports submission packages. Supports filing.

Access: PlatformLimit: Formats not stated source (opens in a new tab)

Cruxi pros and cons

Where Cruxi is strong

Limitations to check before paying

How to use Cruxi for preparing an FDA 510(k) submission

Set up Cruxi

  1. Start free at cruxi.ai
  2. Create a project for your device
  3. Select the FDA 510(k) service

Example: preparing an FDA 510(k) submission

  1. Enter device classification details
  2. Generate draft sections
  3. Run the compliance and RTA checks
  4. Export the submission package

Review and export the result

  1. Review every section against current FDA guidance
  2. Confirm the RTA check passes before filing

Cruxi integrations and API

Native integrations and export formats

Export: Submission packages

API access and separate billing

Cruxi has no public API in its official documentation. Not listed.

Privacy, data use and commercial rights

Summarized from the vendor's current policies; this is not legal advice and a vendor's badge is not an independent audit.

How your inputs and outputs are handled

Handles device and regulatory data.

Site says models are trained on FDA guidance; user data use not stated.

Explore Cruxi further

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    Cruxi FAQ

    How many regulatory services does Cruxi offer?

    14 services covering FDA and global markets, including 510(k), De Novo, Q-Submission and EU MDR. source (opens in a new tab)

    Does Cruxi publish current prices?

    No. The pricing page returns 404 and earlier promo prices expired. source (opens in a new tab)

    Can Cruxi help find 510(k) consultants?

    Yes, it offers consultant and provider directories with quote requests. source (opens in a new tab)

    Does Cruxi require a card to start?

    The homepage says Start Free with no card required. source (opens in a new tab)

    Sources and review methodology

    Official sources and verification dates

    Not verified: Pricing; Privacy policy; Docs; Data handling.

    How we documented and maintain this page

    Every fact about Cruxi above comes from the 2 official pages listed here, last compared on Sep 29, 2026; we have not run Cruxi ourselves, so it has no editorial score. How we check and re-check pages.

    Article updated Oct 2, 2026; prices checked Sep 29, 2026. Outbound links to vendors are plain links; we do not earn commissions. How we review · Report an error