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Ketryx for R&D

Developer-First Solution for Regulated Software

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

Release faster while staying compliant

Enable any development process to be IEC 62304-compliant

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 postmarket surveillance
  • Eliminate the endless commitment spreadsheets that never scale

Automated traceability streamlines FDA compliance

Explore traceability

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
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