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Kusari for Medical Device Cybersecurity
Ensure medical device cybersecurity, FDA 524B compliance, and SBOM transparency with Kusari. Protect patients, ease legacy device headaches and streamline pre-market submissions.
Enabling patient safety through secure software supply chains
Medical devices are powered by open source software components. Your developers didn’t write the code. You don’t directly control it. But once it’s in your device, you’re responsible for its safety and compliance.
Kusari ensures software security for medical devices amid rising threats and growing regulatory scrutiny.
Use our tools to confidently embed security by design, vulnerability management, and transparency for safe use into your process for legacy device software updates and pre-market submissions.
What We Do
Full SBOM generation
For accurate and complete transparency of your components - what you have and where it is
Automated vulnerability detection
To identify and remediate risks early
License compliance monitoring
To reduce legal and operational exposure
Continuous SDLC monitoring
For secure-by-design development and pre-market submissions
We integrate directly into your developers’ IDEs and workflows, so security doesn’t slow innovation—and your teams stay happy and productive.
Learn MoreBuilt for Today’s Medical Device Cybersecurity Landscape
Kusari gives you context and visibility to address these medical device regulations and operationalizes your ability to prepare and comply:
US FDA 524B (FD&C Act, 2023)
Software Bills of Materials (SBOM), vulnerability management, and patching obligations
US FDA Cybersecurity Premarket Guidance (2023)
Secure design, SBOM submission, and lifecycle security requirements
US FDA Postmarket Cybersecurity Guidance (2016)
Ongoing monitoring and vulnerability remediation of new and legacy devices
EU MDR (2017/745) & IVDR (2017/746)
Explicit inclusion of cybersecurity as part of safety and performance
EU Cyber Resilience Act (CRA, 2025–2027)
Will mandate SBOMs, secure updates, and vulnerability handling across all “products with digital elements,” including medical devices
GDPR (2016/679)
Patient data protection and privacy for connected devices
ISO 14971
Risk management for medical devices (includes software security risks)
IMDRF Cybersecurity Guidance (2020/2022)
Baseline international reference for lifecycle cybersecurity
Kusari helps streamline medical device cybersecurity compliance while protecting patients and accelerating your product’s path to market.
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