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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
ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
Credit-based system
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Cruxi
Founded
2024
Country
United States
Website
cruxi.ai
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com