Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No images available
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