Fidelity

Develop Fast.
Stay Compliant.

Continuous compliance visibility throughout your
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Easy to use and to customize
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Clean and minimalist design
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.

Discover

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.

Build

Development & Implementation

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

Test

Verification & Validation

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

Deploy

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

End-to-End Platform for
Regulated Medical Software Development

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

Simple and Fast Continuous Compliance

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 Compliance 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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Design

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)?

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Are you Building a
Software as a Medical Device (SaMD) Application?

What if you could create SaMD products at 10% of today's cost?
Join Ketryx's Startup Waitlist and create your SaMD in weeks, not years.