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End-to-End Platform for
Regulated Medical Software Development
FDA-grade Medical Software Development Platform Built for Agile. Step-by-Step, Compliant-by-Design Workflows turn Regular Developers into Regulated Developers.
Planning & Design
Streamlined, straightforward creation of FDA-compliant software development environments. From Quality Management System setup, to risk analysis and requirements management, Ketryx guides the creation of medical devices.
Development & Implementation
Increase developer productivity and reduce software quality overhead. Ketryx generates compliant-by-design workflows that enable fast and compliant development.
Verification & Validation
Simplify testing management and V&V. Complete traceability connecting risks and requirements to V&V and post-market activities.
Release & Post-Market Surveillance
End-to-end complaint investigation using your favorite task management platform. Perform root cause analysis and manage change in a streamlined and auditable way.
End-to-End Platform for
Regulated Medical Software Development
Creating high-quality medical software is difficult, time-consuming, and unproductive.
But what if it doesn’t need to be?
Simple and Fast Continuous Compliance
Turn your software into an FDA-grade software application using pre-built, automated, and regulated software infrastructure. Create GMP software infrastructure and generate all the documentation needed for a 510(k), DeNovo, and PMA submission.
Machine Learning Compliance
Learn how to follow FDA Good Machine Learning Practice (GMLP). Integrate Real-world Evidence and Continuous ML Validation (CMLV) into your application lifecycle. Take advantage of automated Algorithm Change Protocol workflow, and leverage pre-designed DataOps infrastructure.
Continuous Compliance Visibility
Agile Development
Decentralize decision-making and maintain FDA-required release workflow using Ketryx's phase gate release framework.
Post-Market Surveillance & Real World Evidence
Easily process, analyze, investigate, and report Adverse Events and products complaints. Integrate Real World Evidence (RWE) into your Application Lifecycle. Address complaints, improve quality, and produce FDA-required reports in a straightforward and automated way.
Rerum facilis est et expedita distinctio nam libero
Rerum facilis est et expedita distinctio nam libero
Rerum facilis est et expedita distinctio nam libero
Rerum facilis est et expedita distinctio nam libero
Rerum facilis est et expedita distinctio nam libero
Rerum facilis est et expedita distinctio nam libero
Why is Regulated Development Hard‽
Developing safety-critical software is tedious and error-prone. Teams developing safety-critical software have lower developer productivity and greater turnover than non-safety critical software teams.
What is your Cost of Quality (CoQ)?
Are you Building a
Software as a Medical Device (SaMD) Application?
What if you could create SaMD products at 10% of today's cost?
Join Ketryx's Startup Waitlist and create your SaMD in weeks, not years.
