Connecting secure design, threat modeling, and compliance—aligned with your business goals.
Medical Devices and Healthcare Cybersecurity Support
FDA Cybersecurity Regulatory Compliance
We handle all FDA-facing cybersecurity tasks, ensuring compliance through robust processes, independent testing, and readiness reports.
Customer IT-Sec Liason
We simplify complex client security requirements into actionable strategies, aligning technical teams with compliance expectations to build trust and accelerate sales.
PostMarket Cybersecurity Surveilance
Tala Defender enables instant threat response, ensures FDA compliance with 30-day response and 60-day remediation windows, and reduces security overhead using GenAI.
FDA Cybersecurity Quality System Considerations and Content of Premarket Submissions
We offer end-to-end FDA-facing cybersecurity services—including readiness assessments, eSTAR cybersecurity submissions, support for presub meetings, hold letter responses, and remediation planning—to ensure your product meets all FDA cybersecurity expectations.
FDA Cybersecurity Regulatory Compliance
We deliver FDA-aligned Security Risk Management Plans, assess software anomaly risks, and document all in-field software versions for compliance.
Threat Modeling
We provide comprehensive cybersecurity modelling across all lifecycle stages with clear justification for chosen methodologies, ensuring robust, end-to-end FDA compliance.
Security Architecture & Design
We offer global system and multi-patient harm analysis, design for updateability and key security use cases, and full traceability from design input to implementation and testing.
Metrics & Performance
We track cybersecurity defect density, measure time from threat awareness to update deployment, and test the effectiveness of implemented security controls.
TPSC & Supply Management
We conduct inventory and support level assessments, track end-of-support (EOS) status, analyze known vulnerabilities, and provide cybersecurity risk assessments with compensating controls and defined discovery methods.
Vulnerability Management
We offer comprehensive SBOM management, complete MDS2 documentation, proactive use of the KEV catalog, and robust processes for vulnerability discovery and testing.
Customer IT-Sec Liason
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Translate complex customer IT security requirements
We break down technical security policies into clear, actionable steps, aligning strategies with your business goals and product scope for effective implementation.
Bridge technical teams and customer Compliance
We enable seamless collaboration between engineering, IT, and compliance teams, ensuring all security documentation and controls align with client standards.
Accelerate approvals and build trust
We proactively prepare you for audits, assessments, and reviews, helping strengthen client trust by showcasing security readiness.
Smart Post-Market Surveillance and Vulnerability Management
We help you meet FDA cybersecurity postmarket sureveillance
Real-Time Post-Market Cybersecurity Surveillance with AI
TalaSecure keeps you secure in-market, slashes FDA reporting time from 292 days to seconds, and ensures 30-day report and 60-day recall compliance with automated monitoring.
System-Level Cybersecurity Risk Intelligence
TalaDefender goes beyond the device—monitoring entire systems to capture events, assess broader risks, and flag vulnerabilities across connected devices and infrastructure.
GenAI-Generated Remediation
TalaDefender clearly explains risks without needing a security background and generates remediation plans with compensating controls for both the device and its environment.