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SBOM

Secure Your Medical Device with Ketryx's SBOM Management Software

Manage risk with software bill of materials (SBOM) management for medical devices  

Transform your SBOM into an FDA-compliant SBOM. Ketryx enables teams to generate precise, comprehensive SBOMs in minutes through scanning or SPDX import. See current software configurations, get detailed FDA-ready documentation, ensure medical-grade cybersecurity coverage, track critical FDA-required metrics for vulnerability management, and automate compliance with the PATCH Act. 

The best way to reduce software supply chain risk and comply with FDA Software Bill of Material requirements
Director,  Fortune 500 Medical Device Manufacturer

Generate your FDA-mandated medical device SBOM in minutes

Reduce documentation time up to 80%
Integrate with your preferred DevTools
Included for no cost in our Free Tier
Generate your FDA-compliant SBOM today

Medical device companies struggle to create FDA-compliant SBOMs:

Risky, or unknown, software
dependencies exist in the product
Manual monitoring of software
stack for vulnerabilities
Wasted time hunting and inputting FDA-required
information about software dependencies
Hard to establish traceability to risk management,
lifecycle components, and supplier management
Ketryx automates the entire process of generating and maintaining an FDA-compliant software bill of materials directly from your source code or from an imported SPDX, so you can spend less time building SBOMs and more on critical security and reliability tasks and review. 
Try it in the Ketryx app
How it works

Use a risk-based approach for safer, more secure medical device software

Reduce your documentation cycle, increase R&D efficiency and accelerate time to market

Minimize manual documentation efforts and save over 50 hours of documentation time per cycle. 

Generate FDA-compliant SBOMs from your source code in real time with detailed metadata, including 62304- and OTS-required metadata.
Establish traceability from each vulnerability to design mitigations, compensating controls, and risk transfer documentation.
Allocate resources to solving technical problems and enhancing product reliability.

Achieve 100% software transparency with SBOM tools

Know exactly what software is in your product at all times with a single consolidated view of your open-source supply chain directly from your source code. 

Automatically identify and apply relevant FDA-required compliance metadata and vulnerabilities for each SOUP item, adhering to IEC 62304 and ISO 14971 standards
Continuously monitor vulnerabilities, providing real-time alerts throughout the lifecycle
Perform detailed risk assessments on individual components, ensuring no vulnerability is overlooked

Control releases to ensure medical device audit readiness

By continuously monitoring your software dependencies for vulnerabilities, Ketryx helps prevent releases with unapproved dependencies, ensuring your software remains secure and compliant at all times.

Place open-source dependencies under Part 11-compliant change control, integrating monitoring and control into CI/CD processes
Ensure compliance with Part 11 regulations through electronic signatures for regulatory documentation
Follow straightforward workflows in Ketryx to document vulnerabilities and maintain control 

Utilize SBOM tools to secure your software supply chain

Identify potential risk and security vulnerabilities at a glance with proactive monitoring and alerting to address issues before they impact performance and effectiveness.

Keeping up with security patches is easy to manage and document
See a clear list of items that need to be actioned so you know exactly what needs to be done for each vulnerability 
Lean workflows support risk acceptability per recent FDA guidance, including Part 11-compliant signatures 
Are You Building Medical Software?

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