Elevate Your Medical Device Security and Achieve Regulatory Compliance
Need support with your 510(k) or PMA FDA submission? Or working toward MDR Compliance? We are here to help.
Product Cybersecurity: Navigating FDA and EU MDR Compliance
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Ensure your medical devices are secure and market-ready with Security Pattern’s ARIANNA Platform. Our product security platform supports FDA and EU MDR compliance efforts by generating and maintaining SBOMs, detecting vulnerabilities, automating triaging and prioritization, and easing mitigation and remediation efforts.
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Complement ARIANNA with our consultancy services to make sure you are certification-ready: Threat Modeling and Penetration testing.
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Discover our 4 step offering toward FDA and MDR compliance:
Comprehensive Device Inventory through SBOM and HBOM
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ARIANNA’s strength lies in its ability to deliver unparalleled device models, providing a complete and transparent view of your device components, one of the main artifacts requested by medical regulations.
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From hardware to software, our platform constructs a precise inventory of your device’s components, ensuring comprehensive visibility across the entire device lifecycle. This detailed inventory enables proactive identification and tracking of known vulnerabilities, as well as their evaluation and prompt resolution.
With ARIANNA’s comprehensive approach, you can stay ahead of cybersecurity threats while fully complying with evolving regulatory standards.
ARIANNA’s approach to building Device Models (SBOM+HBOM) is unique. By relying on the build procedure, we reach the highest level of accuracy and no false positives. Automation through APIs makes the maintenance of the components effortless, after every update. In addition, by monitoring the hardware, you can be assured of choosing the most secure hardware for your products and keeping this layer secure throughout the entire life cycle.
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Full control over Device Vulnerabilities through Continuous Monitoring
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The second piece of evidence requested is the implementation of a sound Vulnerability Management Process (VMP). Relying on the Device Model (SBOM+HBOM) as input, the ARIANNA platform continuously monitors your device for known vulnerabilities. The system supports you to define the right priorities, by automated triaging and prioritization based on exploitability. Embedded systems are risky and costly to update; ARIANNA supports you in defining the right time and scope of your software updates.
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ARIANNA highlights Known Exploited Vulnerabilities (KEV), a key consideration for FDA’s prioritization strategy. Those vulnerabilities, proven to have been exploited, are considered high risk and should be managed promptly.
"Device manufacturers should document all software components of a device and address or otherwise mitigate risks associated with these software components."
- FDA Guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, 2023'
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Define Cybersecurity Requirements with Targeted Threat Modeling
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Threat modeling and risk assessment are critical activities in cybersecurity, aimed at identifying, evaluating, and prioritizing potential threats to assets. When integrated into the design and development processes of secure systems, these activities enable the early discovery of security flaws.
The benefits are significant: products and systems can be fortified with mitigations derived from threat modeling, and design decisions can be made in a risk-aware manner, guided by the insights from risk assessment.
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Threat Modeling and Risk assessment are some of the first activities in the Secure Development Life Cycle (SDLC) methodology and stand at the base of a secure product.
"FDA recommends that the cybersecurity risk assessment provided in premarket submissions should capture the risks and controls identified from the threat model. The methods used for scoring the risk pre- and post-mitigation and the associated acceptance criteria as well as the method for transferring security risks into the safety risk assessment process should also be provided as part of the premarket submission."
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- FDA Guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, 2023'
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Validating a Product is Market Ready with Penetration Testing
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Another cornerstone of the Secure Development Life Cycle (SDLC) is the verification of device security, which can be achieved by third-party penetration testing. The goal of penetration testing is to identify weaknesses through in-depth hardware or logical tests.
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We propose a variety of penetration tests to assess the security of a system or device. They are intended to circumvent device security policies and include software, firmware, and hardware techniques, both non-invasive and invasive.
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Using the equipment in our lab, such as our EMFI or Side-Channel setup, our skilled pen testers will mimic the behavior of attackers. Examples of techniques adopted during our penetration tests are fault injection, side channel attacks and protocols/API fuzzing.
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Evidence needed to show compliance to regulation includes: pen testing reports from third parties, stating the duration and scope of the tests performed.
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Security Pattern: Your Cybersecurity Partner
At Security Pattern, we understand the unique challenges faced by medical device manufacturers. From development to deployment, we are committed to being your trusted partner in navigating the complexities of cybersecurity and compliance. With ARIANNA, you gain a powerful toolset to protect your devices, safeguard patient safety, and achieve regulatory compliance seamlessly.
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Ready to enhance your device security? Contact us today to explore how we can help safeguard your innovations and simplify your path to compliance.
Join the growing number of manufacturers who trust Security Pattern to secure their medical devices. Together, we can build a secure and connected healthcare future.
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ARIANNA Platform: SBOM & Vulnerability Management
Blog: The importance of Secure Product Development for Medical Devices
A software bill of materials (SBOM) has become a key element in supply chain security. This list of software components used within a device or system is a topic high on the agenda among regulators, security professionals, and manufacturers.