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What is Threat Detective?

Threat Detective is a specialized software solution aimed at managing Software Bill of Materials (SBOMs) and vulnerabilities, specifically catering to teams operating within the medical device industry. It transforms SBOMs and vulnerability evaluations into cybersecurity documentation that is ready for official submission, maintaining the currency of this documentation through ongoing surveillance after market release. With Threat Detective, teams are empowered to: * Import CycloneDX and SPDX SBOMs effortlessly * Verify the key elements and details within SBOMs * Identify vulnerabilities from numerous advisory platforms * Prioritize findings according to CVSS, EPSS, and CISA KEV standards * Document exploitability, remediation, and mitigation strategies effectively * Generate VEX publications * Develop necessary documentation for FDA, EU MDR, and UK regulatory compliance * Monitor each active device and software version continuously for newly disclosed vulnerabilities Tailored for medical device manufacturers, Threat Detective revolutionizes the conventional spreadsheet approach to vulnerability management by providing a more efficient, auditable system for both premarket assessment and ongoing post-market oversight, which enhances compliance and security throughout the entire product lifecycle. This cutting-edge methodology not only improves operational efficiency but also raises the quality of care delivered in the industry. As a result, organizations can better protect their products and ultimately contribute to safer healthcare outcomes.

What is SmartSolve eQMS?

Simplify monotonous and repetitive activities to allow more focus on delivering products that enhance safety and efficacy, while also increasing speed. IQVIA’s SmartSolve Postmarket Surveillance provides a robust SaaS solution tailored for postmarket surveillance (PMS), offering you best practices for the centralized oversight of all PMS operations. The Fusion event is designed for SmartSolve and RIM Smart users, delivering in-depth education on relevant quality and regulatory topics, along with actionable insights and useful tools that can be utilized within any Life Sciences organization. Originally initiated as a live conference for SmartSolve users, Fusion has evolved over time to include both virtual and in-person sessions for the wider SmartSolve and RIM Smart communities. By adopting the IQVIA SmartSolve™ Regulatory Connector, you can significantly improve your compliance response times, accuracy, predictive planning, and overall operational efficiency. This Connected Intelligence framework exemplifies our innovative, integrated approach aimed at achieving substantial operational improvements for your organization, leading to a multitude of benefits. Keeping pace with these advancements is crucial for ensuring your organization stays relevant and competitive in an ever-changing industry landscape. Such proactive measures will not only enhance your current operations but also position your organization for future success.

Media

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Media

Integrations Supported

Integrations Supported

Indent

API Availability

API Availability

Pricing Information

$189/month/project
Free Trial Offered?

Pricing Information

$542 one-time payment

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
On-Site Training

Company Facts

Organization Name

Threat Detective Ltd

Date Founded

2025

Company Location

United Kingdom

Company Website

threatdetectivehq.com

Company Facts

Organization Name

IQVIA

Date Founded

1982

Company Location

United States

Company Website

www.iqvia.com/solutions/integrated-global-compliance/quality-compliance/smartsolve-eqms

Categories and Features

Categories and Features

Audit

Not specified

Compliance

Not specified

Document Management

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

Quality Management

Audit Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

Not specified

Training

Built-in LMS
Learner Portal

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