What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications
Reduce complexity and costs across your IT systems
Develop faster with automated DHF generation
Empower your developers and engineers with their favorite tools
Control risks with medical-grade cybersecurity
Automated and Traceable
Regulated Software Lifecycle Management
Creating high-quality medical software is difficult, time-consuming, and unproductive.
But what if it doesn’t need to be?
Create FDA-grade Software
Start developing in minutes
Use pre-built GxP Development Infrastructure
Remove non-value add documentation work
Software Development and Traceability
End-to-end traceability using your favorite tools
Continues traceability compliance visibility
Remove non-value add testing
A New Way To Build Regulated Software
Build in Ketryx
Design, Develop, and Deploy
Generate required documentation and evidence
Ad-hoc submission generation documentation generation
Maintain the flexibility of decentralized software development with the structure required for medical products
Save time and effort with compliant-by-design workflows
Continuous Configuration Management
Assure regulated products are configured, safe, and reliable.
Detailed audit-ready configuration
Streamline product testing and release
A Developer-first Solution
to Regulated Software Development
Turn Regular Developers into Regulated Developers
Onboard developers and have them start working in hours, not weeks.
Machine Learning Compliance
Easily generate machine learning model validation reports and DataOps configuration status accounting
How can Ketryx help?
Develop with confidence, maintain control, and prepare your team with the most efficient tools available
Manage requirements individually or as a group using the development tools you know best.
Manage IEC 62304 compliant-by-design development workflows with pre-built guard rails
Make sure your application (SOUP) and cloud configuration meet FDA standards.
Testing & QA
Ingrain Verification and Validation (V&V) into your software lifecycle. Track all phases of testing in a single simple-to-use dashboard.
Build & Release Management
We help to reduce cost, time to market, non-value added work, and turnover among regulated development teams.
Process customer feedback and complaints through a risk-based approach. Connect problem reports and change requests directly to your software lifecycle.
Change Control Management
Automate change control processes and easily generate submission documents. Trace changes across the software lifecycle and reduce your testing overhead.
Audit & Metrics
Guided on-site and remote audits using dashboards designed specifically for medical software audit and compliance. See everything from traceability to complaint trending, all in one view.