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Average Ratings 0 Ratings

Total
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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

Montrium Connect Yes 

Integrations

Montrium Connect No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$189/month/project
Free Trial Yes 
Free Version 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 

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) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

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 No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

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