# Secure Your Medical Device with Ketryx's SBOM Management Software .png) ## 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](https://app.ketryx.com/auth/signin?callbackUrl=https%3A%2F%2Fapp.ketryx.com) ## 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](https://app.ketryx.com/auth/signin?callbackUrl=https%3A%2F%2Fapp.ketryx.com) 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. .png) ### 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 .png) .png) ### 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? ## Get started building software in minutes, not months. [Book a demo](https://www.ketryx.com/schedule-demo)