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Fidelitas Defense

Fidelitas DefenseFidelitas DefenseFidelitas Defense
Home
Solutions
  • Software Assurance
  • Systems Assurance
  • Regulatory Risk
  • Knowledge
Industries
  • Autonomous Vehicles
  • Bulk Power System
  • MedTech
  • Military & Defense
  • Private Cap. & Corp. Dev.
Platform
  • HORIZON-X
Company
  • Leadership Team
  • Newsroom
  • Privacy Policy
Blog
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Regulatory Risk Management

Helping Our Customers Meet Global Regulatory Standards

Our Regulatory Risk Management Solution, powered by HORIZON-X—our dual-use, AI-Native SaaS platform—helps organizations navigate complex global regulations while addressing Systems Assurance, Supply Chain, FOCI, Cyber, and Regulatory Risks across the Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stack.


Using proprietary frameworks, we guide compliance with standards including EO 13920. NIST SP 800-218 SSDF, U.S. Interagency Third-Party Risk Management Guidance & NDAA, NATO STANAG & AQAP, and EU-UK Directives such as NIS2 and the Cyber Resilience Act (CRA). Our approach spans the full PAI-RAS stack—from Hardware and Firmware to Operating Systems, Middleware, AI/ML SDKs (Perception, Planning, Control), and AI Simulation/Testing Environments—enabling organizations to manage regulatory and operational risk across complex systems.


Managed Regulatory Risk Management Service: Beyond our platform, Fidelitas Defense provides Managed Services, including assurance, risk assessment, and training led by SMEs—former U.S. Intelligence Community and military professionals with decades of operational cybersecurity experience. Our experts bring deep, hands-on PAI-RAS risk expertise in high-consequence, regulated environments, delivering mission-aligned guidance and proactive remediation against nation-state, organized crime, insider, and hacktivist threats, along with actionable, defensible insights for organizations in sensitive or classified domains.

Avoiding Catastrophe: Regulatory Compliance in PAI-RAS Systems

Meeting regulatory compliance standards in the Physical AI, Robotics, and Autonomous Systems (PAI-RAS) domain is not just about rules—it is critical for safety, security, and organizational resilience. These systems operate across land, sea, and air, exposing them to risks from hardware malfunctions, firmware/software vulnerabilities, communications failures, AI/ML decision errors, supply chain weaknesses, and cyber threats from nation-state actors, criminal groups, hacktivists, and insiders.

Failing to mitigate these risks can cause physical harm, catastrophic accidents, and property damage. Beyond immediate safety concerns, non-compliance exposes companies to severe legal and financial consequences, including:


· Civil liability and regulatory penalties—including fines up to 2.5% of global annual revenue under EU-UK frameworks like the Cyber Resilience Act (CRA) and AI Act.


· Director and officer liability—fiduciary duties increasingly encompass oversight of cybersecurity and third-party risk; failures may result in shareholder litigation and personal liability for losses from cyber incidents.


· Regulatory enforcement—for failing to meet U.S. Interagency Third-Party Risk Management Guidance, NDAA, EU CRA, UK CSRB standards.


· Reputational damage—eroding stakeholder and customer trust.


In PAI-RAS, regulatory compliance is not optional—it is a core component of risk management. Opaque or inconsistent development practices increase the likelihood of incidents that can trigger catastrophic legal, financial, and operational consequences.

Helping Customers Meet U.S. & EU-UK Regulatory Standards

U.S. Interagency Third-Party Risk Management Guidance (Fed, OCC, FDIC, 2023)

Our U.S. Regulatory Risk Management Solution helps organizations comply with U.S. Interagency Third-Party Risk Management Guidance (Federal Reserve, Office of the Comptroller of the Currency, Federal Deposit Insurance Corporation, 2023) by evaluating Systems Assurance, Supply Chain, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk across their Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stacks. We provide customized guidance and strategic recommendations to strengthen compliance with interagency expectations, including Third-Party Risk Governance, Vendor Oversight, Operational Resilience, and Cybersecurity Controls. 

U.S. National Defense Authorization Act (NDAA)

Our U.S. Regulatory Risk Management Solution helps organizations comply with U.S. NDAA Sections 889, 1260H, 1267, 1654, and 1655 by evaluating Systems Assurance, Supply Chain, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk across their Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stacks. We provide customized guidance and strategic recommendations to strengthen compliance with U.S. NDAA requirements, including Systems Assurance, Technology Diligence, and Cybersecurity Standards. 

UK Cybersecurity & Resilience Bill

Our UK Regulatory Risk Management Solution helps organizations comply with United Kingdom (UK) regulatory requirements by evaluating Systems Assurance, Supply Chain, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk across their Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stacks. We provide customized guidance and strategic recommendations to strengthen compliance with the UK's Systems Assurance and Cybersecurity Standards. 

NATO STANAG, AQAP & Directives

Our NATO Regulatory Risk Management Solution helps organizations comply with NATO STANAG and AQAP regulatory requirements by evaluating Systems Assurance, Supply Chain, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk across their Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stacks. We provide customized guidance and strategic recommendations to strengthen compliance with NATO's Systems Assurance and Cybersecurity Standards. 

European Union (EU) AI Act, NIS2 & Cyber Resilience Act (CRA)

Our EU Regulatory Risk Management Solution helps organizations comply with EU NIS2, Cyber Resilience Act (CRA), and Artificial Intelligence Act (AI Act) regulatory requirements by evaluating Systems Assurance, Supply Chain, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk across their Physical AI, Robotics, and Autonomous Systems (PAI-RAS) technology stacks. We provide customized guidance and strategic recommendations to strengthen compliance with the EU's Systems Assurance and Cybersecurity Standards.   

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  • Regulatory Risk

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