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Introducing Ketryx

Connected lifecycle management for medical device software teams

Automated and traceable

Manage your SDLC across systems

Developing regulated software is complex. Ketryx connects across your systems to impose control on preferred DevTools throughout the lifecycle, from planning to post-market.

Software Manufacturing Process

Planning & Research

Define project scope, objectives, and gather user requirements, while conducting preliminary market and technical research.

Risk Analysis

Identify potential risks associated with the software and assess their impact on patient safety and product performance.


Create detailed software architecture and design specifications, ensuring compliance with regulatory standards.


Write and compile the code based on design specifications, integrating necessary functionalities.


Install the software on the intended hardware or platform for initial testing and use.


Conduct thorough testing, including unit, integration, and system tests, to verify software functionality and reliability.

Verification & Validation

Confirm that the software meets all specified requirements and intended use through rigorous testing and evaluation.

Final Risk Analysis

Reassess risks post-development to ensure all potential hazards have been mitigated or controlled.


Prepare and approve the software for market release, ensuring all regulatory and quality requirements are met.


Distribute the software to end-users or customers, ensuring proper documentation and support are provided.

Postmarket Surveillance

Monitor the software's performance and safety in the market, gathering user feedback and addressing any issues or updates needed.
What is Ketryx?

Regulated software lifecycle management

Change management

Automate change control processes and trace changes across the SDLC.
See how it works


Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Explore Documentation


Ketryx creates a real-time traceability matrix by overlaying product development tools and connecting all items, risks, code, and tests.
Explore traceability

Version control

Use the release dashboard to quickly compare changes between versions.
See how it works

Automated testing

Connect and trace automated tests to requirements, risk controls, and specifications.
How we trace to automated tests


See a single consolidated view of your open-source supply chain directly from your source code.
Explore SBOM

Vulnerability management

Automated vulnerability detection helps you quickly evaluate risk.
Explore Vulnerability Management


Connect your preferred DevTools into a single, traceable SDLC.
See available integrations

Risk management

Proactive monitoring identifies potential risk and security vulnerabilities.
Explore Risk Management
Streamline your workflow

Ketryx integrates with these tools and more

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