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# 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

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Case Study\
**How HeartFlow Reduced Complexity by 90% in 10 Weeks with a System of Systems**](/content/case-studies/heartflow-case-study/index.html)

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White Paper\
**A Guide to Implementing CI/CD in Your AI/ML SaMD Projects**](/content/white-papers/ci-cd-ai-ml-white-paper/index.html)

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Case Study\
**How Beacon Biosignals Reduced Their Release Cycle to Two Weeks for AI/ML Products**](/content/case-studies/beacon-biosignals/index.html)

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Blog\
**PCCP Compliance Guide**](/content/blog/pccp-compliance/index.html)

## 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.

### 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.

### Release faster

Accelerate release speed by 10x without sacrificing quality and safety.

### Streamline change management

Stop recording one change in many places. With Ketryx, changes are documented automatically from your DevTools.

## **“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

## Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.