[Skip to main content](https://www.ketryx.com/function/ai-ml#) [](https://www.ketryx.com/function/ai-ml#) This is some text inside of a div block. AI/ML Leaders in Medical Device Software Development # Validate, monitor, and control your AI systems—with a human in the loop ## Reduce Your Documentation Burden by 90% and Release Your AI Products Faster AI Compliance Software ## AI/ML leaders in medical device software must control, validate, and trace every change to meet FDA and EU requirements. Building regulated AI isn’t like building consumer AI. You're not just training models—you’re proving their safety, enforcing validation protocols, and preparing for audits. ### Change Control Change control is disconnected from development workflows and validation workflows are manual and error-prone. You’re making model updates frequently, and doing manual change management—plus making sure it’s documented, traceable, and aligned with your PCCP—can take weeks. ### Validation Your validation protocol has strict acceptance criteria, and your team needs to follow it to the letter. Enforcing this protocol across fragmented tooling is nearly impossible. ### Data Management Postmarket monitoring is reactive and hard to trace back to specific model versions. And as your training data evolves, you need to track it to ensure population representativeness. ### Resources for AI/ML Leaders in Medical Device Software \\ \\ Case Study\\ **How HeartFlow Reduced Complexity by 90% in 10 Weeks with a System of Systems**](https://www.ketryx.com/case-studies/heartflow-case-study) \\ \\ White Paper\\ **A Guide to Implementing CI/CD in Your AI/ML SaMD Projects**](https://www.ketryx.com/white-papers/ci-cd-ai-ml-white-paper) \\ \\ Case Study\\ **How Beacon Biosignals Reduced Their Release Cycle to Two Weeks for AI/ML Products**](https://www.ketryx.com/case-studies/beacon-biosignals) \\ \\ Blog\\ **PCCP Compliance Guide**](https://www.ketryx.com/blog/pccp-compliance) \\ \\ Case Study\\ **How AI-Powered HeartFlow Reduced Complexity by 90%**](https://www.ketryx.com/case-studies/heartflow-case-study) \\ \\ **How Aignostics is Accelerating AI Development in Medicine with Ketryx**](https://www.ketryx.com/case-studies/aignostics-case-study) FDA-Grade Software for the AI Age ## Helping AI/ML leaders build audit-ready medical device software without the burden of manual documentation Use agile development processes and automation to control all changes and documentation with ease, letting you focus on what you do best: building software. Achieve time-to-value in hours rather than weeks or months. ### Harness LLMs and your preferred tooling for GxP environments Simply connect Ketryx to your current development tools. [Explore Integrations](https://www.ketryx.com/capabilities/integrations) [Integrate with your existing dev stack like Jira, GitHub, and AWS, with the peace of mind that approvals and documentation meet FDA and EU expectations](https://www.ketryx.com/function/ai-ml#) [Utilize Ketryx Agents and the power of LLMs to improve your quality and accelerate release timelines](https://www.ketryx.com/function/ai-ml#) [Use the AI assistant to generate requirements, test cases, and risk controls faster while ensuring accuracy, and sync across connected systems](https://www.ketryx.com/function/ai-ml#) ### Automate documentation and traceability Focus on development, not documentation. No more spending 60% of your time on documentation, reviews, and hand-offs. Reduce errors and time spent copying/pasting data between different systems and documents. [See Documentation](https://www.ketryx.com/capabilities/documentation) [Ketryx automatically traces training data and model versions to requirements, risks, and test executions across Jira, Git, and your MLOps stack](https://www.ketryx.com/function/ai-ml#) [Produce a submission-ready DHF automatically](https://www.ketryx.com/function/ai-ml#) [Ketryx supports AI and cloud-based technologies and simplifies documenting SOUP](https://www.ketryx.com/function/ai-ml#) ### Release faster Accelerate release speed by 10x without sacrificing quality and safety. [How Beacon Biosignals releases every two weeks](https://www.ketryx.com/case-studies/beacon-biosignals) [Save time every release cycle by automatically generating required documentation and traceability, documenting changes and their downstream impacts in a PCCP-compliant way](https://www.ketryx.com/function/ai-ml#) [Use AI agents to surface improvements and traceability links faster while keeping a human in the loop](https://www.ketryx.com/function/ai-ml#) [Chat with the AI assistant throughout your workday to get your questions answered immediately](https://www.ketryx.com/function/ai-ml#) ### Streamline change management Stop recording one change in many places. With Ketryx, changes are documented automatically from your DevTools. [See how it works](https://www.ketryx.com/product) [Ketryx agents analyze your changes and alert you of downstream impacts](https://www.ketryx.com/function/ai-ml#) [Ketryx automatically captures changes as you’re working, documenting everything in your DHF](https://www.ketryx.com/function/ai-ml#) [Enforce your PCCP within all connected systems so changes stay within pre-approved boundaries](https://www.ketryx.com/function/ai-ml#) .png) ## **“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.”** Alex Chan VP of Analytics and Machine Learning at Beacon Biosignals Align Quality with Development ## Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration. [Watch webinar](https://www.ketryx.com/function/ai-ml#) .png)