PRODUCT COMPARISON

Greenlight Guru vs. Ketryx

Ketryx offers traceability. Greenlight Guru delivers the complete QMS your medtech team actually needs and keeps you audit-ready from day one.

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Trusted by 1,000+
medtech companies
worldwide

Aligned with ISO 13485,
FDA QMSR, EU MDR,
and ISO 14971

Supported
thousands of
successful audits

What Greenlight Guru gives you that Ketryx doesn't

Ketryx is a traceability layer built on top of Jira and GitHub. Most medtech teams need more than that. They need a complete QMS that connects product, quality, and regulatory in one audit-ready system.

Feature	Greenlight Guru	Ketryx
Purpose-built for medical devices	✓Exclusively medtech since 2013.	✗Developer traceability tool. Founded 2021.
Complete QMSDoc control, CAPA, training, suppliers, change management	✓Native modules, fully integrated.	✗Traceability layer only. Core QMS functions managed in external tools or spreadsheets.
Document control and change management	✓Versioned, Part 11-compliant, linked to CAPA and training.	✗Flat file storage with basic approvals. No structured change workflows or revision history.
Training management	✓Automated re-training linked to document updates.	✗No training management. Teams track training outside the system.
CAPA and quality events	✓Native CAPA, NC, complaint, and incident workflows	✗CAPAs run in Jira. Incidents not supported natively.
Supplier management	✓Built-in supplier qualification, monitoring, and approvals.	✗No supplier management. Teams bolt on spreadsheets.
Risk management	✓ISO 14971-aligned, linked to design inputs for clear mitigation.	◐Risk tables in Jira only. No multi-framework support. Static, not dynamic.
Multi-framework complianceFDA QMSR, ISO 13485, EU MDR	✓All frameworks managed together, no duplication.	✗Cannot manage multiple frameworks in parallel. Teams duplicate matrices manually.
Dev tool integration	✓Jira, GitHub, and open APIs.	◐Jira-dependent. Breaks down with Linear, GitHub-only, or mixed environments.
Implementation support	✓Medtech experts guide every implementation.	✗Generic tech support. Customers report being unprepared for audits.
Scales post-market	✓Pre-market through post-market in one system.	◐Strong for dev workflows. Post-market and supplier gaps force replatforming as you grow.

See the difference

Why medtech teams choose
Greenlight Guru over Ketryx

Our customers choose Greenlight Guru for an intuitive, scalable QMS solution that’s built just for medtech and is supported by in-house medical device experts who are there to help at every step.

Pre-Market
Medtech

"With Greenlight Guru, the compliance lives in the same space that the engineers are working in. So it's in their code, in their automation, in their release workflows."

Rania deLeonPresident and CEO of Mira Methods and Quality Assurance and Regulatory Affairs Manager, SafeBeat

SaMD / 510(k) Clearance

"Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission. Partnering with Greenlight Guru provides you with a team that's on your side, who are all medical device industry pros."

Ryan NolanCo-Founder / VP of Clinical Operations, PhotoniCare

AI-Powered SaMD / 510(k) Clearance

"Our partnership with Greenlight Guru gives us great QMS software made for us. But also, we get access to so many comprehensive resources and support that help us as a medical device company."

Crystal Womack,Quality Manager,
Avenda Health

Frequently asked questions

How does Greenlight Guru compare to Ketryx?

Greenlight Guru is a purpose-built, end-to-end QMS for medical devices that covers document control, design controls, risk management, CAPA, training, and supplier oversight in one connected, audit-ready system. Ketryx is primarily a traceability layer on top of GitHub and Jira. Teams using it typically rely on Notion, spreadsheets, and other external tools to fill critical QMS gaps. If your goal is full compliance coverage without stitching together multiple platforms, Greenlight Guru was built specifically for that.

Can I migrate from Ketryx to Greenlight Guru?

Yes, and it's more straightforward than you might expect. Greenlight Guru's onboarding team includes regulatory experts and ex-auditors who guide you through every step of the transition, from configuring your workflows to ensuring your records are structured for audit readiness. Most teams are up and running in weeks, not months.

Does Greenlight Guru integrate with Jira and GitHub?

Yes, Greenlight Guru integrates with Jira. But unlike Ketryx, it doesn't require Jira to function. Your QA and regulatory affairs teams work in a system designed around quality workflows, while engineering teams maintain their existing tools. Greenlight Guru also supports teams not using Jira at all, making it a fit for a wider range of development stacks.

Does Greenlight Guru support multiple regulatory frameworks?

Yes. Greenlight Guru is aligned with ISO 13485:2016, FDA QMSR (effective February 2026), EU MDR, and ISO 14971. It also supports managing multiple frameworks in parallel within a single system. Ketryx lacks multi-framework risk support, which becomes a meaningful limitation as your device portfolio or market footprint grows.

Is Greenlight Guru a good QMS for SaMD teams?

Yes, Greenlight Guru is purpose-built for medical device companies, including teams building software as a medical device (SaMD). It supports IEC 62304 workflows alongside ISO 13485, FDA QMSR, and EU MDR requirements, and gives engineering and quality teams a shared system so compliance is built in from the start, not added on at the end. SaMD companies like Photonicare and Avenda Health have used Greenlight Guru to achieve 510(k) clearance and manage their full device lifecycle in one place.

Ready to see the full QMS Ketryx can't offer?

Join 1,000+ medtech teams who rely on Greenlight Guru to move fast and stay compliant, backed by regulatory experts who have supported thousands of successful audits.

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QMSR is coming. Is your quality system ready?