MedTech

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Fidelitas Defense delivers Systems Assurance, Technology Diligence, Foreign Ownership, Control, or Influence (FOCI), Cyber, and Regulatory Risk Management for Physical AI, Robotics, and Autonomous Systems (PAI-RAS) medical technology and safety-critical healthcare infrastructure. Our solutions align with global standards and U.S. and international regulatory guidance — including the U.S. Food and Drug Administration (FDA) Cybersecurity Guidance, International Medical Device Regulators Forum (IMDRF) guidance, and International Electrotechnical Commission (IEC) 62443 and ISO 14971 standards — helping organizations manage risks across complex technology dependencies, foreign ownership exposure, and the Physical AI, Robotics, and Autonomous Systems (PAI-RAS) underpinning patient safety, clinical operations, and healthcare infrastructure integrity.

Fidelitas Defense is focused on serving hospitals and health systems, medical device manufacturers, pharmaceutical companies, Clinical Research Organizations (CROs), healthcare information technology (HIT) providers, medical imaging and diagnostics companies, surgical robotics developers, and healthcare regulators and notified bodies, helping them understand and mitigate operational, cyber, and regulatory risks across their Physical AI, Robotics, and Autonomous medical device and clinical infrastructure environments.