Onboarding is as simple as connecting Ketryx to your current development tools and assigning teams by project and authority. Manage requirements individually or as a group using agile development processes. The Ketryx compliant-by-design approach includes pre-built guardrails to ensure IEC 62304 compliance throughout.

Achieve Time-to-value in hours rather than weeks or months.

Our monthly pricing and flexible contracts make it easy for you to get started. Ketryx overlays your existing tools and workflows – simply point it at your source code and you’ll be up and running in minutes with FDA-ready documentation automatically generated at all stages. Our expert support team is always available to ensure your success.

Ketryx offers predefined, FDA-ready templates and guidance for IEC 62304, ISO 14971, CFR 21 Part 11 built into our software with input from former FDA talent. Instead of worrying about documentation and regulatory hurdles, you can focus on building life-saving products and improving patient outcomes.

As new guidance is issued on critical areas such as security, AI, and ML, we make it easy for you to stay ahead of new requirements. Our expert team continuously releases updates that anticipate new requirements with built-in intelligence.