SRA and Finite State’s Compliance-First Approach to Device Cybersecurity
Security Risk Advisors (SRA) and Finite State are revolutionizing the way device manufacturers navigate cybersecurity compliance. Our strategic partnership combines SRA’s robust security services with Finite State’s advanced SBOM generation tool, providing a comprehensive, compliance-first approach to device security. This synergy accelerates market entry by addressing cybersecurity vulnerabilities swiftly and effectively, leading to seamless compliance with regulations. With SRA and Finite State, device manufacturers can confidently bring their innovations to market, secure and in compliance.
FDA Guidelines for Medical Devices
On December 29, 2022, the Consolidated Appropriations Act, 2023 (“Omnibus”) was signed into law. Section 3305 of the Omnibus—”Ensuring Cybersecurity of Medical Devices”—amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
As of September 2023, the FDA has published its final recommendations regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.
Achieve Compliance and Go to Market Securely!
Identify Gaps in Hardware and Software Security Design
SRA recognizes that modern medical devices are often implemented as systems and even systems-of-systems, complete with integration interfaces and cloud-based infrastructure. Because of this, our medical device assessment methodology differs from more traditional hardware testing in that we consider the wider ecosystem that recognizes that security impacts often extend beyond the test target.
Understand Vulnerabilities and Threats from the Surrounding Network.
SRA understands that contemporary medical devices are not just standalone entities, but part of a complex network of systems and subsystems. We account for the broader ecosystem, acknowledging that potential threats and vulnerabilities may not be confined to the device itself, but could extend to any part of the interconnected system. This holistic approach allows us to identify, analyze and prioritize potential threats in a comprehensive manner, ensuring the highest level of security for the medical device and its surrounding network.
Finite State‘s Next Gen platform features extended SBOM management that ingests and aggregates data from over 150 external sources, giving security teams a unified and prioritized risk view with unprecedented visibility across the software supply chain.
The Next Gen Platform:
- Generates, collects, visualizes, and distributes SBOMs in your supply chain
- Ingests scans from 150+ scanners and feeds, unifying all the tools that defend your product or system in the full context of your environment
- Provides remediation guidance that aggregates and reconciles results across all scans, generated or ingested, for context-aware recommendations
- Decomposes a product or asset into its many components through world-class binary SCA and enhanced SBOM capabilities so you get a laser-focused risk assessment
- Conveys a product’s or system’s risk levels through its robust scoring methodology, backed by sophisticated risk prioritization
- Imports and exports all VEX formats, with advanced vulnerability intelligence correlation
Secure Your Path to Market Today!
Don’t let cybersecurity compliance slow down your innovation. With SRA and Finite State, apply the FDA’s recommendations and expedite your market entry. Contact us now to explore how our comprehensive security services, combined with Finite State’s advanced SBOM generation tool, can provide your business with a robust, compliance-first approach to cybersecurity.