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Develop Fast;
Stay Compliant

Ketryx is the first and only connected lifecycle management software for MedTech that unifies quality and R&D efforts to deliver safer, more innovative software up to 2-3x faster.

Developer-first Solution for Regulated Software Environments

Use the tools you love to focus on development – not duplication

Turn any developer into a regulated developer

Onboarding is as simple as connecting Ketryx to your current development tools and assigning teams by project and authority. Manage requirements individually or as a group using agile development processes. The Ketryx compliant-by-design approach includes pre-built guardrails to ensure IEC 62304 compliance throughout.

Achieve Time-to-value in hours rather than weeks or months.

No more endless spreadsheets; Focus on meaningful work

End duplicate, wasteful scenarios where teams work on the same project, continually stopping for review and hand-offs. Reduce the time spent cutting and pasting data between different systems while minimizing errors. Easily collaborate between teams and different systems to connect processes from user needs and design all the way through product development, release, and post-market surveillance.

Deploy continuous testing for safer, faster product delivery

Embed Verification and Validation (V&V) into your software lifecycle. Use SOUP and Off-the-shelf software components to accelerate dev efforts with the confidence they meet FDA standards. Track all testing phases in a consolidated, at-a-glance dashboard.

Streamline Post-Market Surveillance

Apply a risk-based approach to processing customer feedback and complaints. Easily connect problem reports and change requests across your software lifecycle, making it easy to isolate and document past issues and corrective actions.

Support the cloud, AI/ML technologies that are transforming healthcare without sacrificing compliance

Ketryx is the only software that empowers manufacturers to leverage AI and ML innovations while ensuring compliance. Easily generate machine learning validation reports and configuration status accounting

Reduce Time/Costs of Change Control

Automate change control processes and easily generate FDA-ready submission documents, reducing testing overhead. Trace changes across your software lifecycle, including the creation of a consolidated view that aligns systems, processes, teams, and workflows.

Validated Application Lifecycle

A Developer-first Solution
to Regulated Software Development

Streamline Post-Market Surveillance

Apply a risk-based approach to processing customer feedback and complaints. Easily connect problem reports and change requests across your software lifecycle, making it easy to isolate and document past issues and corrective actions.

Support the cloud, AI/ML technologies that are transforming healthcare without sacrificing compliance

Ketryx is the only software that empowers manufacturers to leverage AI and ML innovations while ensuring compliance. Easily generate machine learning validation reports and configuration status accounting

Reduce Time/Costs of Change Control

Automate change control processes and easily generate FDA-ready submission documents, reducing testing overhead. Trace changes across your software lifecycle, including the creation of a consolidated view that aligns systems, processes, teams, and workflows.

Demo

Are You Building Medical Software?

Ketryx is the first and only connected lifecycle management software designed to enable MedTechs to take advantage of Cloud-based tools while maintaining FDA, cGMP, and ISO compliance