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Developer-first Solution for Regulated Software

Maintain compliance, accelerate development and automatically generate FDA reporting from the tools you know and love

Enable any development process to be 62304 compliant

Onboarding is as simple as connecting Ketryx to your current development tools and assigning teams by project and authority. Use agile development processes and automation to control all changes and documentation with ease, letting you focus on what you do best: building software. Achieve time-to-value in hours rather than weeks or months.

Focus on meaningful work

  • No more spending 60% of your time on reviews and hand-offs
  • Reduce errors and time spent copying/pasting data between different systems.
  • Automatically trace user needs and design all the way through product development, release, and post-market surveillance.
  • Eliminate the endless commitment spreadsheets that never scale

Automated traceability streamlines FDA compliance

Build a defensible system by automatically generating audit trails from the source without having to hunt down spreadsheets and complex interdependencies. Teams no longer need to resort to after-the-fact traceability to attempt to recreate artifacts for compliance purposes that should have been created throughout.

Embed continuous testing throughout your entire lifecycle for safer, faster product delivery

  • Embed Verification and Validation (V&V) into your software lifecycle.
  • Accelerate dev efforts with SOUP and OTS software tools with confidence that they meet FDA standards
  • Keeping up with hotfixes and patches is easier than ever
  • Track all testing phases in a consolidated, at-a-glance dashboard.

Are You Building Medical Software?

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