A Comprehensive Approach to Medical Device Cybersecurity

Proposed 3-Phase Medical Device Penetration Testing Plan

Navigating the complex landscape of medical device cybersecurity requires a structured and professional approach. This plan provides a clear path to compliance, safety, and market readiness, ensuring your devices are secure from design to deployment.

Discovery Session

Our Services

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.

Our Phases

Our Medical Device Penetration Testing Process

We start by defining the testing scope and aligning it with FDA premarket/postmarket requirements and global standards. This ensures penetration testing activities are comprehensive, regulator-ready, and mapped to device risk profiles.

Activities

Map scope to FDA CDRH guidance and IEC/ISO cybersecurity standards
Inventory devices, subsystems, firmware, and IoMT/IT environments
Review existing security documentation (risk assessments, SBOM, vulnerability disclosure policies)
Develop threat models and map attack surfaces to identify high-risk vectors

Deliverables

FDA-aligned test plan, Threat Model Report, Gap Analysis Report

Activities

Perform vulnerability assessments on authentication, encryption, APIs, data flows, wireless/wired communication
Execute penetration testing and exploitation attempts to validate CIA (Confidentiality, Integrity, Availability) controls
Assess lifecycle security (patch/update processes, end-of-life considerations)
Document findings with actionable mitigation recommendations

Deliverables

Premarket Penetration Test Report (FDA-ready), Risk Register with CVSS Scoring, Remediation Roadmap

Activities

Evaluate effectiveness of postmarket monitoring and detection mechanisms
Test incident response and recovery readiness through simulated attacks
Validate patch management and secure update workflows
Assess third-party and supply chain components for hidden risks

Deliverables

Postmarket Penetration Test Report, Incident Response Readiness Report, Supply Chain Security Assessment, Final FDA-Ready Compliance 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

Medical Device Penetration Testing - Key Benefits

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

Key Benefits

End-to-end penetration testing aligned with FDA and global standards
Early detection and mitigation of critical vulnerabilities before market release
Continuous security validation across device lifecycle (premarket + postmarket)
Stronger regulator confidence with FDA/EU submission-ready reports

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

Integrate testing early in design, maintain SBOMs and security documentation, and implement continuous monitoring with a robust incident response plan for lifecycle-wide protection.

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 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.

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?