FDA Compliance Software & Regulatory Lifecycle Management Tools all in one.
Automatic DHF Generation from your Dev Tools
Ketryx automatically generates your Design History File (DHF) from source systems, eliminating error-prone copying/pasting from the disconnected systems commonly found in MedTech.
Ketryx doesn’t replace existing tools, such as quality systems and workflows—it sits on top of them, connecting compliance and dev activities in one collaborative environment. With total process control, teams are aligned to reduce risk and the associated costs of warnings or recalls while delivering better patient outcomes.
Enforce SOPs in Your Dev Tools
Developed by experts in regulatory compliance, Ketryx features guardrails that enforce SOPs exactly as written across multiple systems. No project can progress unless it is fully compliant.
Engineers are free to code in their preferred tools and still be compliant, increasing satisfaction and minimizing churn.
Automatically Connected and Navigable Traceability Across All Systems
Ketryx integrates all of your development tools and automatically connects all of the documentation, tests, and code into one FDA-compliant traceable and navigable system preventing launches without complete traceable and auditable compliance with your QMS.
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