Skip to main content

Build safer FDA-compliant software. Faster.

Ketryx enables life sciences teams to use their preferred DevTools and automation to generate evidence, real-time traceability, and prevent process deviation.

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 validated to, and helps teams comply with, medical device standards 13485, 14971, and 62304.

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.

  • Automatically generate an FDA-compliant design history file (DHF) sourced directly from modern development tools like Jira, GitHub, and AWS.
  • Ensure real-time consistency between documentation and all data, text, code, and tests stored in development tools.
  • Release higher quality products faster with real-time traceability across Jira and all connected systems, documentation, and tests.

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.
Our Customers
Oui Therapeutics
Beacon Biosignals

Are You Building Medical Software?

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