Accelerate Cybersecurity Risk Management for FDA Submissions

Aithra (pronounced eye-thra) is redefining how medical device manufacturers approach cybersecurity compliance. Developed by our partner BG Networks, this AI-powered platform leverages advanced LLMs to automate and streamline threat modeling and risk assessments, making it faster and easier to produce reliable, FDA-compliant documentation.

Simplify SPDF Compliance with Automated Risk Assessments

Whether you're part of a large team or submitting to the FDA for the first time, Aithra adapts to your workflow, simplifying compliance by generating comprehensive, SPDF-aligned assessments in minutes. 

From the moment your system description is ready, Aithra begins identifying potential security risks and recommending appropriate controls, allowing you to address vulnerabilities early in the design phase. As threats evolve, Aithra continuously updates your risk assessments to keep you aligned with the latest threat intelligence.

Aithra is Purpose-Built for Medtech

With its clear, export-ready reports that seamlessly integrate into your submission package, Aithra gives you the speed and confidence to meet regulatory demands while maintaining rigorous standards of security and compliance.

  • Asset identification
  • STRIDE-based threat modeling
  • Damage scenario
  • Attack path enumeration
  • Risk assesment