Fidelity

What is Ketryx?

End-to-end DevOps platform for regulated medical applications

Reduce complexity and costs across your IT systems

Develop faster with automated FDA software compliance

Empower your developers and engineers with their favorite tools

Control risks with medical-grade cybersecurity

TIMES
GOOD
COMPANY
App Store
STARTUP
REPORT
QUICK
REPORT
Validated Application Lifecycle

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

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

Validated Application Lifecycle

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

Agile Development

Utilise Compliant-by-Design workflows to remove waste from you development processes

Validated Application Lifecycle

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.