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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
Integrations
Validated Application Lifecycle

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
Our partners
Oui Therapeutics
Beacon Biosignals
Talkiatry
Docbox
Empyrean
Validated Application Lifecycle

How can Ketryx help?

Develop with confidence, maintain control, and prepare your team with the most efficient tools available
Capabilities

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?

Create regulated applications 3X faster.
Get started building software in minutes, not months.
Get startedBook a demo