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Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?
Integrate a risk-based approach across your medical software development lifecycle
FDA-grade medical software development platform built for Agile. Step-by-step, compliant-by-design workflows turn regular developers into regulated developers.
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.
Increase developer productivity and reduce software quality overhead. Ketryx generates compliant-by-design workflows that enable fast and compliant development.
Simplify testing management and V&V. Complete traceability connecting risks and requirements to V&V and post-market activities.
End-to-end complaint investigation using your favorite task management platform. Perform root cause analysis and manage change in a streamlined and auditable way.
Creating high-quality medical software is difficult, time-consuming, and unproductive.
But what if it doesn’t need to be?
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.
Read More ->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.
Read More ->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.
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
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.
Read More ->
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)?
Create regulated applications 2-3X faster.
Get started building software in minutes, not months.
© 2023 Ketryx Corporation
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