A Professional Visual Guide to Securing Your Medical Devices

Medical Device Cybersecurity:Validation Testing

Navigating the complex landscape of medical device cybersecurity requires a structured and professional approach. Our services provide a clear path to compliance, safety, and market readiness, guiding you through each stage from design to deployment.

Discovery Session

Our Services

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.

Our Phases

Our Medical Device Cybersecurity Validation Testing Process

We begin by establishing a strong foundation for cybersecurity.

Activities

Develop a security test plan aligned with FDA, EU MDR, IEC 62304, and IEC 62443
Define VAPT scope across all connected interfaces (network, BLE, Wi-Fi, LTE, USB, cloud)
Map device assets and data flows for visibility into critical components
Develop realistic threat scenarios and perform initial risk prioritization

Deliverables

Security Test Plan & Threat Modeling Report

Activities

Perform penetration testing of firmware, APIs, wired/wireless interfaces, and cloud services
Combine automated tools with manual testing techniques, including fuzzing (BLE, TCP/IP, USB)
Validate critical security controls such as authentication, secure boot, firmware updates, and data protection

Deliverables

Vulnerability & Penetration Testing Report

Activities

Deliver detailed reports with CVSS-based scoring and prioritized remediation guidance
Provide compliance mapping to FDA Premarket Guidance, EU MDR Annex I, ISO/IEC standards
Prepare regulator-ready documentation for audits and submissions

Deliverables

Final Cybersecurity Validation & Compliance Report

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

Medical Device Cybersecurity Validation Testing - Key Benefits

Building security in from the ground up, not as an afterthought.

Key Benefits

Strengthens device security against emerging threats and exploits.
Reduces time to market with regulator-ready reports and documentation.
Builds long-term trust with healthcare providers and patients.
Minimizes costly late-stage redesigns by addressing risks early.

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

Manufacturers should embed cybersecurity in device design by conducting comprehensive risk assessments, ensuring compliance with standards such as FDA, ISO 14971, IEC 62304/81001, and UL 2900. Regularly review and document security processes, implement robust access controls, encryption, and patch management, and maintain ongoing monitoring to promptly address vulnerabilities.

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.

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.

Ready to move from uncertainty to a position of confidence?