Medical Device Quality Management System Software

Enforce your QMS across preferred DevTools

Ketryx embeds engineering controls that let developers move faster, have fewer meetings, and code more – while still ensuring compliance. Infuse quality into every stage of the product life cycle, ensuring quality at the source and compliance throughout the process.

I’ve been looking for this tool all my life!

Senior Director of Agile Transformation

Is enforcing your QMS slowing your time to market?

Large medical device companies have hundreds of developers working concurrently, remotely and around the world, on many different features, and in many different versions, for one release. With this level of complexity, it’s impossible – and risky – to rely on manual enforcement of your QMS procedures.

We can only release every 24 months.

QMS Software

Reduce risk with medical device engineering controls

The Benefits of Medical Device Compliance by Design

Gain control and complete transparency for software releases and ensure FDA compliance prior to launch of any new product or version.

Rapidly onboard and keep developers happy by eliminating time spent referencing or verifying procedures.

Guardrails automatically stop any product from progressing until it is compliant, turning any developer into a regulated developer.

Prevent process deviation by enforcing your standard operating procedures in development tools like Jira and GitHub.

The right actions in the right order

Ensure that traceability is established before release with built-in controls in Jira.

Part 11-compliant signatures and configurable approval rules create streamlined workflows.

Maintain FDA-compliant data integrity

Live traceability tracks changes to avoid errors common in copy-pasting data across different systems.

SOPs are built into Ketryx to provide checks and prevent errors as developers work across risk-based projects.

Learn more about traceability

Prevent QMS process deviation

Built-in coaching in Jira and GitHub highlights the highest risk items and their dependencies.

The work developers do in their preferred DevTools, like Jira and GitHub, automatically syncs across systems, gating deployment in any connected system according to your SOPs.

Keep your medical device secure and compliant

Enable true CI/CD while maintaining full FDA compliance with enforcement built into your tools.

Ensure that only approved open-source versions are released into production.

… without sacrificing speed

Higher quality doesn’t need to mean slower development.

See how Beacon Biosignals achieved two-week development cycles.

Read the case study