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Develop Fast.
Stay Compliant.

Integrate a risk-based approach across your medical software development lifecycle

Continuous compliance visibility throughout your

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Validated Application Lifecycle

End-to-End Platform for
Regulated Medical Software Development

FDA-grade medical software development platform built for Agile. Step-by-step, compliant-by-design workflows turn regular developers into regulated developers.


Planning & Design

Streamlined, straightforward creation of FDA-compliant software development environments. From Quality Management System setup, to risk analysis and requirements management, Ketryx guides the creation of medical devices.


Development & Implementation

Increase developer productivity and reduce software quality overhead. Ketryx generates compliant-by-design workflows that enable fast and compliant development.


Verification & Validation

Simplify testing management and V&V. Complete traceability connecting risks and requirements to V&V and post-market activities.


Release & Post-Market Surveillance

End-to-end complaint investigation using your favorite task management platform. Perform root cause analysis and manage change in a streamlined and auditable way.

Validated Application Lifecycle

Modern DevOps Tools for
Streamlined FDA Compliance

Creating high-quality medical software is difficult, time-consuming, and unproductive.
But what if it doesn’t need to be?

Simple and Continuous Control

Turn your software into an FDA-grade software application using pre-built, automated, and regulated software infrastructure. Create GMP software infrastructure and generate all the documentation needed for a 510(k), DeNovo, and PMA submission.

Machine Learning Compliance

Learn how to follow FDA Good Machine Learning Practice (GMLP). Integrate real-world evidence and Continuous ML Validation (CMLV) into your application lifecycle. Take advantage of automated Algorithm Change Protocol workflow, and leverage pre-designed DataOps infrastructure.

Continuous System Visibility

Passive and Active Product Surveillance

Compliant with IEC 62304, ISO 14971, CFR 21 Part 11

End-to-end GxP compliance visibility across your Software Development Life Cycle (SDLC). Automated workflows, remote audit, and extensive governance features.

Agile Development

Decentralize decision-making and maintain FDA-required release workflow using Ketryx's phase gate release framework.

Increase Velocity

Automatically generate all needed submission documents

Streamline V&V

Compliant-by-design workflows

Post-Market Surveillance & Real World Evidence

Easily process, analyze, investigate, and report Adverse Events and products complaints. Integrate Real World Evidence (RWE) into your Application Lifecycle. Address complaints, improve quality, and produce FDA-required reports in a straightforward and automated way.

Get compliant faster then ever

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Machine Learning Compliance

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Continues Compliance Visability

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Agile Development

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Post-Market Survilance

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Real-world Evidance

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Why is Regulated Development Hard?

Developing safety-critical software is tedious and error-prone. Teams developing safety-critical software have lower developer productivity and greater turnover than non-safety critical software teams.

What is your Cost of Quality (CoQ)?

Download White Paper

Are You Building Medical Software?

What if you could create regulated applications at 10% of today's cost?
Get started building software in minutes, not months.