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.
Capabilities
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.
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
Capabilities
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 desperate 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
"The only developer first FDA-grade software platform."
Head of Test, Aetion
Are You Building Medical Software?
Create regulated applications 3X faster.
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