Software as a Medical Device. Success starts with the right tools.

Reduce the complexity, time, and cost of building SaMD applications with the only developer-first regulated software development platform

Get Started with Ketryx

Drowning in detail

Maintaining all FDA-required evidence and documentation is difficult and error-prone. The endless torrent of incoming data needs to be organized carefully, and current tools are not equipped to support each necessary step of safety-critical software development, leading to higher expenses and slow development cycles.

Open Source Integration

End-to-End Traceability

Submission Generation

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

20-year medical software veteran

Are you building a‍ Software as a Medical Device?

What if you could create SaMD products at 10% of today's cost?
Get started building SaMDs in weeks, not years.

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