Securing Medical Devices from Design to Decommission

SBOM & Vulnerability Assessments

Our structured service plan is designed to support medical device manufacturers and SaMD (Software as a Medical Device) startups in meeting both pre-market and post-market compliance requirements. Focused on Software Bill of Materials (SBOM) and vulnerability management, this service plan aligns with FDA, EU MDR, and other global regulatory frameworks.

Discovery Session

Our Services

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.

Our Phases

Our SBOM & Vulnerability Assessments Process

We create a transparent inventory of all software components, including open-source and third-party libraries.

Activities

Inventory and document all software components (open source, proprietary, commercial off-the-shelf) used in the medical device, including those within firmware and connectivity layers.
Structure SBOMs and metadata to seamlessly integrate with FDA Premarket Submission (e.g. 510(k)), EU MDR technical documentation, and Health Canada requirements—covering all NTIA minimum fields (component name, supplier, version, support status, etc.).
Include support details, support end dates, and update responsibilities for all components to address regulatory expectations.

Deliverables

Complete inventory of all software components (open source, proprietary, COTS, firmware, connectivity).
FDA/EU MDR/Health Canada–aligned SBOM with NTIA minimum fields (name, supplier, version, support status, etc.).
Metadata and documentation ready for regulatory submissions (510(k), MDR tech files).
Support details and update responsibilities defined for each component.

Activities

Assess all listed components using advanced Software Composition Analysis (SCA) tools and NIST/NVD feeds for known vulnerabilities (CVEs).
Map identified vulnerabilities to device functions and patient safety impacts, prioritizing based on exploitability and criticality in alignment with ISO 14971 and IEC 62304 risk controls.
Deliver actionable recommendations and integration points for software updates, patches, and compensating controls, all referenced within the SBOM.
Compile vulnerability assessment reports and mitigation plans required for FDA acceptance and MDR/Health Canada equivalency.

Deliverables

Automated vulnerability scan results (SCA tools, NIST/NVD feeds, CVE listings).
Risk mapping of vulnerabilities to device functions and patient safety (aligned with ISO 14971 & IEC 62304).
Prioritized vulnerability list by exploitability and clinical impact.
Remediation roadmap with software update, patch, or compensating control guidance.
Regulatory-ready vulnerability assessment reports with mitigation strategies.

Activities

Support ongoing SBOM revisions to capture new releases, patches, or changes triggered by software updates, third-party support changes, or regulatory actions.
Provide ongoing monitoring and alerting for emerging threats, facilitate Vulnerability Exploitability eXchange (VEX) statements, and enable timely postmarket disclosure and response for both the FDA and end customers.
Supply real-time SBOMs, vulnerability status, and documented fixes during audits, postmarket surveillance, or customer/hospital security requests—demonstrating proactivity and compliance throughout the device lifecycle.s
Offer secure portals or evidence packages for regulators and end users, supporting market trust and procurement requirements from security-conscious hospitals and integrators.

Deliverables

Updated SBOMs reflecting new releases, patches, and third-party changes.
Updated SBOMs reflecting new releases, patches, and third-party changes.
Continuous monitoring and alerts for new vulnerabilities.
VEX (Vulnerability Exploitability eXchange) statements for regulators and hospitals.
Real-time SBOMs and vulnerability status reports for audits and surveillance.
Evidence packages/secure portal access for regulators and customers (to support procurement and trust)

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

SBOM & Vulnerability Assessments- Key Benefits

Medical devices are increasingly software-driven, making them vulnerable to risks hidden in open-source and third-party components. Without robust SBOMs and continuous vulnerability management, manufacturers face regulatory delays, patient safety concerns, and loss of trust with regulators, hospitals, and end users.

Key Benefits

Our SBOM & Vulnerability Assessments service ensures regulatory-aligned transparency across premarket and postmarket stages.
By generating structured SBOMs, identifying and remediating vulnerabilities, and enabling real-time monitoring, we help manufacturers minimize cyber risks, accelerate FDA/EU MDR submissions, and meet procurement requirements.
The result: safer devices, smoother audits, and sustained compliance throughout the product lifecycle.

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

SBOM vulnerability management is not a one-time process—ongoing monitoring, assessment, and updating are essential as software evolves and new threats emergeManufacturers should use SBOMs for routine risk management, vulnerability identification, and incident response. When new vulnerabilities are found, SBOMs help correlate affected assets, prioritize patching, and verify remediation

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.

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 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?