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About

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.

About

Create your own OSHA-compliant Safety Data Sheets (SDSs) in GHS format. Press a button and watch the SDS appear as an editable word-processing document. For the price that a consultant might charge to produce one or two SDSs, you can have your own SDS generator for all of your products. Included with the program is a generator for OSHA-mandated GHS labels. Also available as an option is the inventory and production manager, for preparing batches, maintaining raw material and product inventories, and more. One-time purchase with optional annual upgrades. Prepare an unlimited number of SDSs, with no per-page or per-SDS charges. Organized just like an SDS, with tabs that represent the individual sections and sub-sections of the SDS. Streamlined interface with color field titles to indicate the most important items to enter. Offers unlimited levels of mixture components when you add an ingredient that is itself a mixture.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical companies, regulatory consultants

Audience

Companies in search of a solution to create and manage their safety and compliance documents

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

Credit-based system
Free Version
Free Trial

Pricing

$1,395 one-time payment
Free Version
Free Trial

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 3.0 / 5

Reviews/Ratings

Overall 3.0 / 5
ease 3.0 / 5
features 3.0 / 5
design 4.0 / 5
support 2.0 / 5

Pros & Cons from Real Users

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

Pros & Cons from Real Users

Pros

  • Software is relatively easy to use once you learn how to navigate your way around. It is well priced for what it does.

Cons

  • Too many bugs and inconsistencies meaning you really need to know what you are doing to rely on the SDS created.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Cruxi
Founded: 2024
United States
cruxi.ai

Company Information

SDScribe
United States
www.sdscribe.com

Alternatives

RAMS

RAMS

Emergo by UL

Alternatives

waiting

waiting

Python Software Foundation
Labrynth AI

Labrynth AI

Labrynth

Categories

Categories

Integrations

No info available.

Integrations

No info available.
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