SECURITY
AUTOMATED
AITHRA: AI-powered Automation for Threat Modeling and Risk Assessment
10x Time Savings:
A New Approach for Cybersecurity Risk Management that Meets FDA Expectations
Aithra’s AI-driven threat-and-risk assessment dramatically cuts prep time and “ Refuse to Accept “ hold risk — putting your 510(k) on the fast track to FDA clearance.
Sign up for immediate evaluation access to use Aithra for threat modeling and risk assessments
Aithra is a groundbreaking, LLM-powered Threat Modeling and Risk Assessment tool for medical devices that complies with FDA recognized standards.
With three steps, Aithra will generate an FDA compliant threat and risk assessment.
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Gather existing medical device documentation and diagrams
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Upload PDFs and/or images to Aithra
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Click Generate Report
Contact us for a sample Aithra-generated threat and risk assessment or demo.
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Efficiency gain
Reduces time to create a threat model and risk assessment by 10x
FDA ready
Compliant to FDA requirements for pre-market submissions
Easy to use
No more diagramming – drag and drop a system description only
Comprehensive
More threats and risks identified compared to if done manually
Documents for eStar
Creates information for “Threat Model”, “ Cybersecurity Risk Assessment”, “Requirements” eSTAR documents
Integrated Cybersecurity Offerings
Webinar Series
Cybersecurity: Practical Advice for FDA’s 510(k) Requirements
Partners
