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 requires no training to use. Simply provide it a text or block diagram description of your system and within 20 minutes it will generate a complete threat and risk assessment report for your medical device.
All that is needed is the following 3 steps:
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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
