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Software as a Medical Device.

Bring Your Designs to Life with the Right Tools

Reduce the complexity, time, and cost of building SaMD applications with the only developer-first connected lifecycle management platform.

Focus on Life-saving Innovations

Reduce the time spent on documentation to focus on product impact. All too often, software developers new to safety-critical environments struggle to integrate modern software development methodology with the documentation required to ensure patient safety and regulatory compliance.

Minimize Open Source Risk

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End-to-End Traceability

Accelerate submissions

The Benefits of Ketryx

Designed to increase developer productivity and reduce quality overhead with built-in compliance, Ketryx integrates common development tools like Jira or GitHub into a single traceable Software Development Lifecycle.
  • Accelerate time to market with our streamlined, end-to-end SDLC
  • Streamline FDA compliance across your IT systems with a single source of truth
  • Manage everything from requirements to Open Source Software (OSS) in one place
  • Reduce developer friction and remove waste with embedded risk analysis
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Higher productivity. Greater control.

Connect IT systems, collect evidence, and empower your development team to build safe and reliable medical software applications with ease

Open Source Supply Chain Management

  • Create a single source of truth for your FDA-compliant Software Bill of Materials (SBoM) and SOUP
  • Guided cyber risk analysis and reliablity analysis
  • Daily automatic surveillance of your application security (AppSec) across your software portfolio

Continuous System Visibility

  • Connect your disparate IT systems into a single validated SDLC
  • Ensure all configuration items, software dependencies, and cloud services are validated, up to date, and approved
  • Compliant with IEC 62304, ISO 14971, 21 CFR  Part 11 and relevant FDA guidances

Easy, Actionable Guidance

  • Guided Change Control
  • Automatically generate all design control documents, testing reports, and other required artifacts
  • Compliant-by-Design Workflows

Maintain Digital Knowledge Continuity

  • Understand and categorize each item in your system with simple, readable labels
  • Trace team actions, keep every team member up to date with the latest data, and follow actionable prompts
  • Use a self-contained system and lower the barrier for onboarding and teaching new team members
"We spoke to dozens of quality experts and nobody ever made anything clear to us. The team at Ketryx did. For the first time, they helped us really understand how to develop compliant software and use Jira effectively as a lifecycle management tool. With Ketryx, our team is truly happy and productive."
Alec Winogrod
VP Engineering, Oui Therapeutics

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