Discover a new way to develop regulated software
Software as a Medical Device. Success starts with the right tools.
Reduce the complexity, time, and cost of building SaMD applications with the only developer-first regulated software development platform
Drowning in detail
Maintaining all FDA-required evidence and documentation is difficult and error-prone. The endless torrent of incoming data needs to be organized carefully, and current tools are not equipped to support each necessary step of safety-critical software development, leading to higher expenses and slow development cycles.
The Benefits
of Ketryx
Designed to increase developer productivity and reduce quality overhead with built-in compliance, Ketryx integrates common development tools like Jira or GitHub into a single traceable Software Development Lifecycle.
Higher productivity. Greater control.
Connect IT systems, collect evidence, and empower your development team to build safe and reliable medical software applications with ease
Open Source Supply Chain Management



Continuous System Visibility

Easy, Actionable Guidance



Maintain Digital Knowledge Continuity

The only developer first FDA-grade
software platform
Are you building a Software as a Medical Device?
What if you could create SaMD products at 10% of today's cost?
Get started building SaMDs in weeks, not years.