Cruxi

Cruxi

5.0 out of 5 stars
RAMS

RAMS

Emergo by UL
Cruxi RAMS

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Cruxi:

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.
RAMS:

About

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance.
Cruxi:

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
RAMS:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
Cruxi:

Audience

Medical companies, regulatory consultants
RAMS:

Audience

Regulatory affairs professionals looking for a solution to streamline compliance processes and maintain up-to-date knowledge of global regulatory requirements
Cruxi:

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported
RAMS:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported
Cruxi:

API

Offers API Not Supported
RAMS:

API

Offers API Not Supported
Cruxi:

Screenshots and Videos

RAMS:

Screenshots and Videos

Cruxi:

Pricing

Credit-based system
Free Version Not Supported
Free Trial Not Supported
RAMS:

Pricing

No information available.
Free Version Not Supported
Free Trial Supported
Cruxi:

Reviews/Ratings

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

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
Cruxi:

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
Cruxi:

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported
RAMS:

Training

Documentation Supported
Webinars Supported
Live Online Not Supported
In Person Supported
Cruxi:

Company Information

Cruxi
Founded: 2024
United States
cruxi.ai
RAMS:

Company Information

Emergo by UL
United States
www.emergobyul.com/software/regulatory-affairs-management-suite
Cruxi:

Alternatives

RAMS

RAMS

Emergo by UL
RAMS:

Alternatives

Cruxi:
RAMS:
Cruxi

Cruxi

5.0 out of 5 stars
Cruxi:
RAMS:
MedAffairs AI

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)
Cruxi:
waiting

waiting

Python Software Foundation
RAMS:
Cruxi:
RAMS:
LICENSALE

LICENSALE

Arazy Group
Cruxi:

Categories

Medical Affairs Supported
RAMS:

Categories

Medical Affairs Supported
Cruxi:

Integrations

No info available.
RAMS:

Integrations

No info available.
Cruxi:
Claim Cruxi and update features and information
Claim Cruxi and update features and information
RAMS:
Claim RAMS and update features and information
Claim RAMS and update features and information