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Description

Flinn serves as an AI-powered platform designed to enhance and simplify the regulatory and quality management tasks within the medical device (MedTech) sector. By allowing manufacturers to incorporate artificial intelligence into intricate and repetitive processes such as post-market surveillance, literature reviews, complaint management, and safety database monitoring, it significantly lessens the manual workload and helps ensure adherence to regulations like the EU Medical Device Regulation (MDR). The platform consolidates information from various sources, utilizes machine learning techniques to identify trends and potential risks, automatically produces reports that meet regulatory standards, and facilitates the swift introduction and operation of high-quality products on a larger scale. Consequently, organizations can realize up to a tenfold increase in process efficiency while also preserving the auditability, transparency, and traceability of their compliance procedures. This innovative approach not only streamlines operations but also empowers companies to focus on innovation and quality in their product offerings.

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

No details available.

Integrations

No details available.

Pricing Details

No price information available.
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

Flinn

Founded

2022

Country

Austria

Website

www.flinn.ai/

Vendor Details

Company Name

Threat Detective Ltd

Founded

2025

Country

United Kingdom

Website

threatdetectivehq.com

Product Features

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