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Ketryx for Start-ups

We understand the regulatory challenges you face in bringing your innovations to life. We’ve helped our customers scale by eliminating the compliance burden that paralyzes many start-ups. With Ketryx, you’re able maintain agility by using Jira and other modern software development tools while achieving 62304 compliance.
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Focus on product impact

Ketryx offers predefined, FDA-ready templates and guidance for IEC 62304, ISO 14971, CFR 21 Part 11 embedded into the software based on 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.

We grow as you grow

With Ketryx, you buy only what you need—there’s no minimum commitment, and you can purchase more licenses and capabilities as you grow. Our monthly pricing and flexible contracts make it easy 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.  FDA-ready documentation is automatically generated at all stages.

Achieve time to value in hours; expert support is always available

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. Our expert support team is always available to ensure your success.

Stay on top of regulatory guidance

Regulations will continue to change in critical areas like security and AI/ML. Ketryx makes it easy for you to stay ahead of new requirements with continuous releases, updates, and built-in guardrails that anticipate and automate compliance with new requirements.