From Design to Decommission: A Comprehensive Security Roadmap

Medical Device Cybersecurity Assessment

In a world where every medical device carries the potential to save or compromise a life, security is a mandate. We help you transform cybersecurity from a reactive burden into a competitive advantage.

Discovery Session

Our Services

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.

Our Phases

Our Medical Device CyberSecurity Assessment Process

Security must be built into medical devices from the start. In this phase, we identify attack surfaces, map threats to patient safety and data integrity, and define critical security controls.

Activities

Review FDA, Health Canada, EU MDR cybersecurity guidance.
Identify hardware, firmware, software, and connected interfaces (IoMT/cloud).
Identify attack vectors (wireless, USB, APIs, supply chain).
Map threats to patient safety, confidentiality, integrity, and availability.
Define security controls: encryption, authentication, access control, secure boot.

Deliverables

Threat model document
Risk assessment matrix
Preliminary security architecture & control requirement

Activities

Software/firmware analysis, SBOM validation.
Automated scanning for CVEs and OSS/library risks.
Simulated attacks (network, wireless, cloud, physical access).
API security, data encryption, PHI handling.
Updates, patch management, end-of-life considerations.

Deliverables

Vulnerability assessment report
Penetration testing report
Software Bill of Materials (SBOM)
Regulatory-ready compliance documentation

Activities

Continuous tracking of device components and libraries.
Simulation of breach scenarios, communication protocols.
Secure delivery, validation of updates.
Evaluation of third-party components and dependencies.
Lessons learned fed into the next device iteration.

Deliverables

Postmarket monitoring report
Incident response plan & readiness checklist
Patch management logs
Continuous improvement & compliance roadmap

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 Assessment- Key Benefits

Provides end-to-end security validation across device design, premarket, and postmarket stages, reducing vulnerabilities and enhancing regulator confidence.

Key Benefits

Our Cybersecurity Assessment service helps manufacturers build resilience from design through postmarket surveillance.
By aligning with FDA, EU MDR, and Health Canada guidance, performing penetration testing, and enabling continuous monitoring, we strengthen device security and ensure compliance.
This proactive approach accelerates regulatory submissions, reduces cyber risks, and builds trust with healthcare providers and patients.

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 adopt a lifecycle approach to cybersecurity—starting with secure design, validated by rigorous testing, and sustained through postmarket monitoring. Proactive updates, vulnerability tracking, and supply chain oversight ensure devices remain compliant and trusted. This approach also prevents costly recalls or regulatory delays. Integrate cybersecurity from design to deployment, maintain continuous monitoring and patch management, and align all documentation with FDA/EU compliance 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.signed for connected medical devices and SaMD solutions. Our methodology ensures early identification of cybersecurity risks while aligning with regulatory frameworks.

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.

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?