Tackle compliance head-on, minimize risk, and be confident you’re shipping the highest-quality medical device software.
Partner with a leader that understands medical device manufacturer needs
Navigating the medical device landscape can be complex, so it’s especially important to select a partner with medical device security knowledge and expertise.. Black Duck is a key contributor in developing the secure design guidance documentation put out by leading agencies, consortiums, and working groups. Also, you can feel confident in partnering with us knowing that the world’s leading medical device manufacturers trust us to secure their most critical software devices and applications.
Let us help you navigate the complex medical device compliance landscape
The guidance and standards outlined by the FDA, IEEE, NTIA, MDISS, MDIC, AAMI, and NIST can be difficult to implement. Our medical device security services team of industry experts is poised to help you address:
- IEC 62304
- UL 2900-2-1
- AAMI TIR57
- FDA 510 (K)
- FDA Premarket Cybersecurity Guidelines
From security program strategy and planning to device- and protocol-specific security testing, our medical device security solutions are tailored to your exact cyber security needs.
Find and fix security defects in proprietary and third-party code
Static analysis helps you find and fix security defects in your proprietary code as it’s built. Uncover even more when you integrate software composition analysis (SCA). Black Duck® SCA generates a comprehensive open source bill of materials (BOM), which you can easily export in SPDX format to help you build out a full software bill of materials (SBOM). Combining SAST and SCA allows you to track and manage security, quality, and license risks and meet anticipated pre-market guidance outlined by the FDA.
Address security issues before they ship
Medical devices use a diverse set of protocols, such as Bluetooth, HL7, and DICOM, that have the potential to carry zero-day vulnerabilities. With Defensics® Fuzzing, you can proactively detect security defects during development and testing and avoid having to respond to breaches and device failures in the field.
Solutions for securing your medical devices
Black Duck SCA
Black Duck Static Analysis
Defensics Fuzzing
Medical devices have unique security requirements. We get it.
Five best practices for medical device security
Build security into connected medical devices
Cheat Sheet: Your Recipe for an Actionable SBOM
Securing Connected Medical Devices for FDA Submissions