Related Products
|
||||||
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
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market.
Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
For more information, visit our website.
|
|||||
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
|
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
|
|||||
Audience
Medical companies, regulatory consultants
|
Audience
Medical Devices, Pharmaceuticals, and IVD companies
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Not Supported
|
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Not Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
Credit-based system
Free Version
Not Supported
Free Trial
Not Supported
|
PricingContact us to learn more.
Free Version
Not Supported
Free Trial
Not Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Pros & Cons from Real UsersPros
Cons
|
Pros & Cons from Real UsersPros
Cons
|
|||||
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
|
Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
|
|||||
Company InformationCruxi
Founded: 2024
United States
cruxi.ai
|
Company InformationRegDesk
Founded: 2014
United States
www.regdesk.co
|
|||||
Alternatives |
Alternatives |
|||||
|
|
|
|||||
|
|
||||||
|
|
||||||
|
|
|
|||||
Categories |
Categories |
|||||
Integrations
Active Directory
Not Supported
Arena
Not Supported
Asana
Not Supported
Boomi
Not Supported
Dynamics 365 Customer Service
Not Supported
Jira
Not Supported
MuleSoft Anypoint Platform
Not Supported
Okta
Not Supported
OpenText AI Operations Management
Not Supported
Oracle ADF Faces
Not Supported
|
Integrations
Active Directory
Supported
Arena
Supported
Asana
Supported
Boomi
Supported
Dynamics 365 Customer Service
Supported
Jira
Supported
MuleSoft Anypoint Platform
Supported
Okta
Supported
OpenText AI Operations Management
Supported
Oracle ADF Faces
Supported
|
|||||
|
|
|