Average Ratings 1 Rating
Average Ratings 0 Ratings
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.
Description
Enhance the speed at which products reach the market by organizing, implementing, and monitoring all regulatory processes within a cohesive RIM application that offers easy access to regulatory documentation and comprehensive support for major eCTD submission standards. The integrated automation simplifies workflows, minimizing administrative tasks and increasing trust in the quality of product registration data. By utilizing this unified approach, organizations can ensure a more efficient regulatory process while maintaining high standards of compliance and accuracy.
API Access
Has API
No
API Access
Has API
No
Integrations
LifeSphere eTMF
No
Pricing Details
Credit-based system
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Cruxi
Founded
2024
Country
United States
Website
cruxi.ai
Vendor Details
Company Name
ArisGlobal
Founded
1987
Country
United States
Website
www.arisglobal.com/lifesphere/regulatory/rims-software/