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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
Engage with healthcare stakeholders to gather valuable insights, enhance clinical research efforts, and promote online learning opportunities. Discover how collaborating with ExtendMed can significantly increase the value and frequency of your engagements while reducing costs to a third of conventional methods. Our expertise can help you extend your influence and effectiveness in the healthcare landscape. With two decades of experience collaborating with pharmaceutical firms, agencies, and associations, we offer comprehensive solutions in scientific, marketing, education, and training through our Health Expert Connect platform, which includes services such as:
- Organizing virtual advisory boards to foster discussion and feedback
- Managing speaker bureaus, including contracting, training, logistics, and compliance with Sunshine reporting
- Facilitating smartphone engagement at events, encompassing sign-ins, presentation slides, polling, surveys, assessments, and follow-up activities
- Hosting online product theaters and satellite symposia to showcase innovations and advancements in healthcare.
By leveraging our platform, you can ensure that your initiatives resonate more effectively with your audience.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
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Integrations
No details available.
Integrations
No details available.
Pricing Details
Credit-based system
Free Trial
No
Free Version
No
Pricing Details
Custom
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)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Cruxi
Founded
2024
Country
United States
Website
cruxi.ai
Vendor Details
Company Name
ExtendMed
Founded
2000
Country
United States
Website
www.extendmed.com