GREENLIGHT GURU VS KETRYX

Your team deserves more than a developer tool dressed up as a QMS.

Ketryx is purpose-built for software engineers. Greenlight Guru is purpose-built for your entire medtech team — quality, regulatory, clinical, and product — from pre-market through post-market.

✓The only eQMS designed exclusively for medical device companies since 2013
✓Full QMS coverage: document control, CAPA, audits, design controls, risk, suppliers, training
✓Aligned with FDA QMSR, ISO 13485, EU MDR — out of the box, no customization
✓Trusted by 1,100+ medical device companies globally
✓Go live in weeks, not months — with expert-led onboarding

Form

Trusted by 1000+ medical device companies

Side-by-side comparison

How Greenlight Guru and Ketryx compare

Ketryx is an impressive tool for software teams managing code compliance in Jira and GitHub. But if your organization needs a complete, audit-ready QMS — one that works for your QA, RA, clinical, and product teams together — Greenlight Guru is built for exactly that.

⚠ Key consideration before you choose

Ketryx was founded in 2021 and is primarily positioned as an ALM tool for SaMD software developers. If your team needs a full eQMS covering document control, CAPA, supplier management, training, post-market surveillance, and clinical data — Ketryx requires significant workarounds or third-party tools to fill those gaps. Greenlight Guru covers all of this in one connected platform.

Capability	✅ Greenlight Guru	Ketryx
Purpose-built for medical devices	Yes — since 2013, exclusively MedTech	Primarily SaMD / software-heavy devices; founded 2021
Full QMS coverage Doc control, CAPA, audits, training, suppliers, NCs	✓ Complete, out of the box	◑ Core features present; gaps in supplier management, post-market surveillance
Design controls & risk management ISO 14971, DHF/DMR, traceability matrix	✓ Full traceability matrix, AI-powered suggestions	✓ Strong for software-linked traceability via Jira/GitHub
FDA QMSR alignment	✓ Built-in workflows aligned with QMSR final rule	◑ FDA 21 CFR Part 820/11 focus; QMSR alignment not explicitly documented
ISO 13485 compliance	✓ Audit-tested workflows and templates included	◑ Supported, but primarily through integrations
EU MDR / IVDR support	✓ PMCF, PMS, EU MDR-aligned workflows	✗ Limited EU MDR-specific workflows documented
Clinical data management (EDC)	✓ Full clinical trials, ePRO/eCOA, PMCF module	✗ Not offered
Non-software / hardware device teams	✓ Built for all MedTech orgs regardless of product type	✗ Workflow centers around Jira/GitHub; less relevant for hardware QA teams
Pre-built regulatory templates	✓ Audit-tested SOPs, DHF templates, checklists	◑ Focuses on auto-generated docs from dev activity
In-house MedTech regulatory expertise	✓ Industry experts embedded in onboarding & support	◑ Engineering-led team; regulatory depth primarily for software standards
Implementation time	Weeks — expert-guided onboarding, out-of-the-box	Weeks for software teams; longer for broader QMS rollout
Customers	1,100+ medical device companies	Trusted by select large manufacturers; newer market entrant

◑ = Partial coverage or requires third-party integration. Last reviewed March 2026.

Why teams switch

What Greenlight Guru gives you that Ketryx doesn't

Ketryx solves a real problem for software developers. But most MedTech quality teams need more than a developer-centric tool — they need a system that spans the entire device lifecycle and every function of the organization.

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Built for your whole team, not just engineering

QA, RA, clinical, product, and executive teams all work in one connected system. No more silos between quality and development — and no need for separate tools for hardware vs. software teams.

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Comprehensive QMS from day one

Document control, CAPA, nonconformances, audits, supplier management, training, and post-market surveillance — all in one place, all connected, all audit-ready. Ketryx covers some of this, but not all.

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QMSR, ISO 13485, and EU MDR — covered

Unlike tools built primarily for US software regulations, Greenlight Guru supports FDA QMSR, ISO 13485, and EU MDR in a single system — critical for companies selling globally.

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Up and running in weeks, not months

Pre-built, audit-tested templates mean you're not starting from scratch. Expert-guided onboarding means your team hits the ground running — without needing to map everything to developer toolchains.

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Clinical data management included

Need to run clinical trials or manage PMCF? Greenlight Guru's clinical module handles EDC, ePRO/eCOA, and PMCF — fully integrated with your QMS. Ketryx doesn't offer this.

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A decade of MedTech-only focus

Greenlight Guru has been building exclusively for medical device companies since 2013. That depth of domain expertise is embedded in every workflow, template, and piece of customer support.

What customers say

Trusted by teams that can't afford compliance gaps

"Our auditors told us, 'Wow, you're steps ahead of anyone else.' Greenlight Guru has differentiated us from other start-ups."

Amy Papranec

VP of Clinical Operations, Critical Care Diagnostics

"Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission."

Ryan Nolan

Co-Founder / VP of Clinical Operations, Photonicare

"I was a little nervous going into the audit, because it seemed too effortless. Your flow is better than the custom solution at a Fortune 500 company I used to work at."

QA Director

Greenlight Guru Customer

"The traceability present across the entire QMS is my favorite part. It makes remote collaboration so much more effective."

Design Controls User