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Build FDA-compliant software with higher quality.

Ketryx enables life sciences teams to use their preferred DevTools and automation to generate evidence, real-time traceability, and prevent process deviation.
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We exist to reduce complexity across your total product life cycle, accelerate your time to market, and reduce your cost of compliance risk.

Our Customers

What is Ketryx

A developer first total product lifecycle management platform built to use your preferred DevTools

Use your preferred DevTools

Ketryx deeply and natively integrates with best-in-class DevTools like Jira, GitHub, GitLab, and AWS.

Automate your Documentation

Ketryx automatically generates Part-11 compliant evidence, including traceability, from the work being done in your preferred DevTools.

Process Enforcement

Ketryx acts as a quality agent across all connected systems, coaching and enforcing your QMS processes directly in your preferred DevTools.

Integrations

See our full list of integrations

Traceability

Real-time navigable traceability across Jira and Git repositories

Jira

Transform your Jira instance into 62304 compliance

Open Source

Use open source libraries with confidence

Evidence

Guarantee audit readiness before a release

Improved quality and compliance

Automated documentation provides teams significantly more time to focus on big risks—not on managing your Design History File (DHF) or Technical File.

  • Automated documentation provides teams significantly more time to focus on big risks.
  • Ketryx embeds QMS procedures into Jira and other development tools making process deviation impossible.
  • Ketryx is UL certified to, and helps teams comply with, medical device standards 13485, 14971, and 62304.
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Release Faster

Release safer software faster using automation to generate documentation, traceability, and streamline processes.

  • Ketryx can be integrated with CI/CD pipelines so that teams can guarantee their releases are fully compliant before going live.
  • Save significant time every release cycle by automatically generating required documentation and traceability for each release.
  • Search and use filters across the lifecycle to quickly track changes between versions, find gaps and focus efforts.

Automatic documentation and traceability

Ketryx automatically generates compliant documentation from any connected system and maintains traceability across the lifecycle.

Filter view to quickly identify gaps.
Compare traceability between versions.
Quickly identify all directly traced items
Tickets automatically connected, synced, and updated in real time with Jira.
Automatically ingest automated tests directly run in your Git repository.

Learn more about Ketryx automation

Automated DocumentationAutomated Traceability

Make developers impactful

Ketryx makes developers more productive and reduces attrition by providing automated documentation and process coaching right in their preferred dev tools.

  • Development teams are free to use preferred modern development tools like Jira, GitHub, and AWS.
  • Ketryx makes any connected system Part 11-compliant, enabling development teams to stay in their dev tools.
  • Development teams can focus on technical challenges instead of documentation and process.

Are You Building Medical Software?

Create regulated applications 3X faster.
Get started building software in minutes, not months.
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