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
Automated and traceable
Regulated software lifecycle management
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
Generate Submission
- 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
How can Ketryx help?
Requirements Management
Manage requirements individually or as a group using the development tools you know best.
Development Management
Manage IEC 62304 compliant-by-design development workflows with pre-built guard rails
Configuration Management
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.
Post-Market Surveillance
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.
Are You Building Medical Software?
Get started building software in minutes, not months.