Trying to address customers’ cyber security needs and fulfill regulatory requirements can seem like an impossible task. To meet demands, you need to keep up with changing compliance requirements, test against a unique set of variables, and make sure software is shipped absent of flaws. With Black Duck tools and services, you can 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 risk assessments and architecture reviews, to device- and protocol-specific security testing, our medical device security solutions combine tools and services 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.
Tools, planning, and services for securing your medical devices
Black Duck SCA
Ensure transparency of open source use, detect known vulnerabilities, and manage license compliance obligations.
Learn moreEmbedded software testing
Get a combination of communication, client, and server analysis to assess the risk of your embedded medical devices.
Learn moreBlack Duck Static Analysis
Find and fix security weaknesses and quality issues in your code as it’s being developed.
Learn moreArchitectural risk analysis
Receive a dependency and known attack analysis with results ranked by technical risk.
Learn moreDefensics fuzzing
Test common APIs and protocols found in medical devices for weaknesses and vulnerabilities.
Learn moreSecurity testing services
Use our security-as-a-service (SaaS) toolkit to run on-demand tests ranging from dynamic and static analysis to pen testing and mobile application testing.
Learn moreThreat modeling
Assess, prioritize, and defend against the attack vectors most likely to exploit the weaknesses found in medical device software.
Learn moreFive best practices for medical device security
We understand medical devices’ unique security requirements and constraints
Cheat Sheet: Your Recipe for an Actionable SBOM
Recommendations you should consider when finetuning your SBOM efforts
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Build security into connected medical devices
Learn about the latest trends, compliance requirements, and tools and services to ensure that you’re delivering the highest-quality medical device software.
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