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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
Gain all the necessary resources to effectively register your medical device or IVD product in global markets while overseeing your market access license throughout the product's life cycle. REGISLATE® equips users with comprehensive submission file requirements tailored to specific medical and IVD device needs for each country. With this platform, you can monitor milestones, timelines, as well as estimated and actual completion dates for initial registrations, renewals, amendments, and license transfers as they happen. Additionally, it offers infographic data and exclusive indicators to facilitate transparent oversight and management of every project. Take advantage of collaboration tools that assist in the preparation and review of submissions, ensuring compliance with all necessary requirements and documentation. Stay informed with real-time progress reports on both current and upcoming submissions, including insights into market access readiness. Furthermore, REGISLATE® features GR-MAP registration tracking, providing comprehensive oversight for both the country and product involved. This holistic approach ensures that users are well-equipped to navigate the complexities of market access efficiently.
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
Arazy Group
Country
Canada
Website
arazygroup.com/regislate-software/