Cybersecurity Baseline Assessment

Without a Software Bill of Materials, you can’t show what software components are in your device or whether they have known vulnerabilities. FDA 2023 and MDCG 2019-16 require an SBOM maintained throughout the product lifecycle.

STRIDE and MITRE ATT&CK-based threat modelling are expected by FDA, notified bodies, and enterprise procurement teams. Without a formal threat model, your security posture is undocumented and cannot be presented as regulatory submission evidence.

New vulnerabilities in open-source and third-party components emerge daily. Without CVE monitoring linked to your SBOM, you can’t identify newly exploitable components or demonstrate a documented post-market response process.

FDA’s 2023 Guidance requires a Cybersecurity Management Plan for 510(k) and PMA submissions, while MDR expects equivalent evidence. Pen test screenshots and informal security notes are not enough. Regulators and reviewers can tell the difference.

Structured threat model using STRIDE and MITRE ATT&CK for ICS/healthcare. Covers your full attack surface, threat actors, entry points, and control gaps. Formatted for direct inclusion in FDA 510(k)/PMA and MDR technical files.

Machine-readable Software Bill of Materials listing all third-party and open-source components with version and licence data. Aligned with FDA's 2023 requirement to submit an SBOM with every new medical device application.

Automated CVE monitoring pipeline tied to your SBOM — tooling, alert thresholds, and a documented response workflow. Enables ongoing post-market cybersecurity vigilance you can demonstrate to FDA and notified bodies.

Risk-ranked security findings with CVSS-based exploitability scores, remediation actions, effort estimates, and a sequenced 90-day action plan to reach a fully defensible, regulator-ready security baseline.