Smart Medical Device Cyber Risk Management | Medical Aegis

The Medical Aegis SaaS Platform

Meet the source system for all things related to digital health technology cybersecurity risk management.

Fully Formed SBOM

Our platform uses industry standards to automatically produce a fully formed software bill of materials, empowering you to identify software and component vulnerabilities before malicious third-parties exploit them and enhancing supply chain transparency with payers, providers, and patients.

AI-based Analytics

Medical Aegis constantly monitors and analyzes you and your competitors components and associated vulnerabilities enabling you to internalize data-driven decision-making.

Proprietary Algorithms

Our predictive algorithm overlays the digital health technology development process to allow customers to research, understand, track, report on, and mitigate risks before going to market.


A robust platform, built with intelligence

We're revolutionizing how manufacturers address the FDA and other regulatory authorities' cybersecurity requirements, simplifying the path to the marketplace.

Predictive Risk Analyzer

Our platform boasts the AI-based capability to collect relevant and disparate information, analyze it, and create a risk profile based on device components. In turn, this makes recommendations for testing and risk mitigation.

Digital Laboratory

Our digital lab is built based on the device type and is driven by the workflow. It allows for real-time collaboration and deep customization to meet your unique analysis, testing, and mitigation needs.

Workflow Automation

Our workflow automation tool is built based on the knowledge that each device may have unique regulatory testing requirements. Each workflow in turn guides the user through the recommended testing procedures.

Single Pane of Glass

Our customizable analysis dashboard provides you with the ability to fully track, report on, and visualize the security posture and dynamic risk profile of your devices throughout the product development lifecycle.

Consulting SERVICES

How we deliver results

Our flagship platform is supported by a suite of comprehensive services focused on digital health technology security and compliance.

Device Risk Management

Our risk management offering includes the exhaustive search, collection, and analysis of you and your competitors assets' vulnerabilities and recommends controls that mitigate risks and their associated impacts based on a predictive algorithm.

Cybersecurity Risk Filing

By working with your product team, we create, test, and track the cyber risks and components vulnerabilities and package this information as part of the FDA requirements for easy submission.

SBOM Generation and Monitoring

Our platform builds and maintains your SBOM for you so you can focus on functionality. We track and alert you on vulnerabilities as they occur throughout the product lifecycle.

Lifecycle Management

Secure design as a core part of the product development lifecycle is more effective than post-launch security. We specialize in securing medical devices throughout the product development lifecycle with and understanding of your devices' functional requirements.

Process Maturation & Optimization

We assist you in assessing, maturing, and optimizing your development cadence through improved processes that include threat modeling, penetration testing, static and dynamic application security testing, risk management, and comprehensive mitigation.

Product Testing & Evaluation

We help you meet the FDA and other global cybersecurity guidelines including assessing risk , pre-market submission requirements; 510(k), De Novo, PMA, IDE, and HDE.

Schedule your free demo​

Learn how Medical Aegis shifts risk to the left and simplifies the cost to comply with regulations​.