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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

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