Ensures Early Identification of Cybersecurity Risks

Threat Modeling and Vulnerability Assessments

Our comprehensive approach to medical device cybersecurity is best visualized through a structured lifecycle, with dual phases of security integration: Pre-Market and Post-Market.

Discovery Session

Our services

Threat Modeling and Vulnerability Assessments

Our Threat Modeling and Vulnerability Assessment service provides a structured approach to identifying and mitigating cybersecurity risks in connected medical devices and SaMD solutions. By aligning with global regulatory frameworks such as FDA Premarket Guidance, EU MDR, IEC 62443, and ISO 14971, we help manufacturers proactively secure their devices, reduce risk, and streamline premarket and postmarket compliance.

Our Phases

Our Threat Modeling and Vulnerability Assessments Process

We map device assets, interfaces, and data flows, then define realistic threat scenarios to evaluate potential risks.

Activities

Identify assets, attack surfaces, and external interfaces (wired, wireless, cloud, firmware, mobile apps)
Define threat scenarios and misuse cases
Conduct risk assessment and prioritization based on likelihood, impact, and patient safety

Deliverables

Asset & System Diagrams, Threat Models, Risk Assessment Matrix, Regulatory Mapping Report

Activities

Implement mitigation strategies: encryption, authentication, secure boot, firmware validation, device hardening
Evaluate effectiveness of existing controls
Map controls to regulatory requirements

Deliverables

Security Controls Matrix, Gap Analysis Report, Implementation Recommendations

Activities

Conduct penetration testing and vulnerability scanning
Develop traceable workflows and a digital audit trail for compliance.
Test device resilience against real-world attacks
Perform standards-based validation per FDA, EU MDR, and IEC 62443 frameworks

Deliverables

Vulnerability Assessment Report, Penetration Testing Report, Remediation Guidance Document, Regulatory Compliance Evidence Package

Our Process

Cybersecurity Evaluation Process

Securing the Future of Connected Health

A proactive, data-driven approach to Medical Device Cybersecurity that ensures safety, compliance, and patient trust from concept to market.

CyberSecurity Data Driven Insights for C-Suite Executives

Benefits

Threat Modeling and Vulnerability Assessments - Key Benefits

Proactively identifies and mitigates cybersecurity risks, strengthens device security posture, and ensures alignment with regulatory standards for faster premarket approval and safer postmarket performance.

Key Benefits

End-to-end protection across device lifecycle
Faster FDA/EU MDR approvals through aligned testing
Minimized risk of data breaches and patient harm
Ongoing resilience with proactive threat intelligence

Why Our Structured Approach Matters

This tailored approach directly supports our core differentiator - the integrated, end-to-end solution by focusing on All-in-One AI/ML and Cybersecurity Solution, from Report to Roadmap and continuous partnership Premarket to Post-Market.

Our Methodology

Recommendations

Key Recommendation for
Manufacturers

Incorporate threat modeling early in design, continuously monitor vulnerabilities, and implement security controls with traceable documentation to maintain compliance and protect patient safety throughout the device lifecycle.

Looking for Something Else ?

Rigorous testing to ensure the device is ready for regulatory approval and market release.

Health-Canada-Penetration-Testing

We provide end-to-end penetration testing for medical devices, aligned with Health Canada’s Medical Device Regulations (MDR) and global cybersecurity standards (ISO 14971, IEC 62304, IEC 81001-5-1). Our structured 3-phase approach ensures medical devices are secure, compliant, and resilient throughout their lifecycle — from design to postmarket monitoring.

SBOM & Vulnerability Assessments

Regulatory-focused 3-phase structured service plan to market SBOM (Software Bill of Materials) and vulnerability management services to medical device manufacturers and SaMD startups. This plan emphasizes pre-market and post-market compliance under FDA, EU MDR, and other global regulations. The objective of this service offering is to meet and exceed current and future regulatory requirements while reducing cyber risk, streamlining submissions, and building customer trust in the security and transparency of their devices.

Medical Device CyberSecurity Assessment

The Medical Device Cybersecurity Assessment provides a comprehensive, lifecycle-focused framework to secure connected devices against evolving threats. Our approach integrates regulatory guidance from FDA, EU MDR, and Health Canada with rigorous design reviews, penetration testing, and postmarket monitoring. By embedding security from the earliest stages through ongoing surveillance, manufacturers can reduce cyber risk, accelerate approvals, and maintain long-term patient trust and regulatory compliance.

Medical Device Penetration Testing

Our Penetration Testing Services provide medical device manufacturers with rigorous, regulator-aligned assessments to validate cybersecurity resilience before and after market release. By integrating FDA premarket/postmarket guidance, EU MDR, and IEC standards, we help organizations reduce vulnerabilities, accelerate compliance, and safeguard patient safety across the full device lifecycle.

Medical Device Cybersecurity Validation & Testing

Our Cybersecurity Validation Testing methodology integrates global regulatory standards (FDA, EU MDR, IEC 62304/62443) with proven security best practices. We help manufacturers strengthen device resilience, achieve faster regulatory approval, and build long-term trust with patients and healthcare providers.

Ready to move from uncertainty to a position of confidence?