//AI SECURITY & GOVERNANCE

We support manufacturers preparing 510(k), De Novo, and PMA submissions with AI-specific cybersecurity documentation: cybersecurity management plan, threat model, SBOM, and security architecture documentation aligned to FDA's 2025 final guidance.

For adaptive AI/ML systems, we design change management and post-market monitoring programmes that satisfy FDA's Total Product Lifecycle approach — addressing the unique challenge of AI systems that update after deployment.

We provide cybersecurity documentation that FDA reviewers expect, reducing premarket submission cycles and post-market deficiency letters.

We build AI governance frameworks for pharma organisations that align to existing quality management systems — covering AI inventory, risk classification, validation documentation for GxP environments, and audit trail requirements.

We interpret ICH E6(R3) and EU AI Act requirements for clinical trial AI specifically — helping organisations understand what compliance looks like for AI tools used in patient selection, trial management, and pharmacovigilance.

Our frameworks are proportionate to risk and designed to integrate with existing QMS processes rather than requiring re-architecture.

We provide enterprise AI assurance programmes for health systems deploying AI at scale — giving boards, commissioners, and risk committees the independent assurance they require. Continuous oversight, regular framework reviews, and incident response readiness.

We conduct independent AI security due diligence for health systems procuring AI from third-party vendors — assessing security posture, regulatory readiness, and governance maturity before contracts are signed.

Our assurance documentation is designed to satisfy NHS England AI Framework requirements, CQC inspection expectations, and the evidence demands of NHS commissioners.

We provide CREST-accredited AI security assessments covering threat vectors that standard penetration testing misses: prompt injection, adversarial inputs, model supply chain attacks, and AI agent attack surfaces in clinical environments.

Our assessments produce cybersecurity documentation in the format required for FDA premarket submissions, MHRA technical files, and notified body review under EU MDR — not just a penetration test report.

For AI agents operating in clinical or operational environments, we assess audit trail completeness, access controls, human oversight implementation, and kill switch design.