What is Ketryx?
- 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
How can Ketryx help?
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.