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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

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

Screenshots View All

Screenshots View All

No images available

Integrations

Montrium Connect

Integrations

Montrium Connect

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

Montrium

Country

Canada

Website

www.montrium.com

Vendor Details

Company Name

Threat Detective Ltd

Founded

2025

Country

United Kingdom

Website

threatdetectivehq.com

Product Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

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