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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
Threat Detective is specialized software designed for managing SBOMs and vulnerabilities specifically tailored for teams in the medical device sector.
Transform your SBOM and vulnerability assessments into cybersecurity evidence that is ready for submission, while ensuring that this evidence remains up-to-date through ongoing post-market surveillance.
Threat Detective empowers teams to:
* Import CycloneDX and SPDX SBOMs
* Verify the contents and essential components of SBOMs
* Detect vulnerabilities from a variety of advisory sources
* Rank findings based on CVSS, EPSS, and CISA KEV
* Record exploitability, remediation, and mitigation strategies
* Publish VEX
* Create documentation for FDA, EU MDR, and UK regulatory processes
* Continuously track each active device and software version for newly revealed vulnerabilities
Designed specifically for medical device manufacturers, Threat Detective modernizes traditional spreadsheet-based vulnerability management by offering a streamlined, auditable framework for both premarket review and continuous post-market monitoring, ensuring compliance and enhanced security throughout the product lifecycle. This innovative approach not only increases efficiency but also elevates the standard of care within the industry.
API Access
Has API
API Access
Has API
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Integrations
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Integrations
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Pricing Details
Credit-based system
Free Trial
Free Version
Pricing Details
$189/month/project
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
Threat Detective Ltd
Founded
2025
Country
United Kingdom
Website
threatdetectivehq.com