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Discover a new way to develop regulated software
Our team will be in-touch with you soon to start your regulated development journey
What is Ketryx?
Total Product Life Cycle (TPLC) platform for regulated medical applications
COMPANY
REPORT
REPORT
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
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Software Development and Traceability
A New Way To Build Regulated Software
Generate Submission
Continuous Configuration Management
A Developer-first Solution
to Regulated Software Development
How can Ketryx help?
Develop with confidence, maintain control, and prepare your team with the most efficient tools available
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.
