CompareGreenlight Guru vs Ketryx
from $12k/yr
Buyers report $21–55k a year (Vendr)
Choose it if: You build a medical device, want design controls, ISO 14971 risk and quality events linked in one MedTech-only system, and can budget well above the entry price.
Watch out: Users report the bill growing quickly as the team grows, and implementation is charged on top of the subscription.
on request
No public or reported prices for paid plans
Choose it if: You build software as a medical device, your engineers live in Jira and Git, and you want design controls, risk and IEC 62304 records generated from that work.
Watch out: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS.
| Greenlight Guru 7.4 | Ketryx 6.5 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 5.5 from $12k/yr Buyers report $21–55k a year (Vendr) | 4.0 on request No public or reported prices for paid plans |
| Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website. | 5.0 Starting price only Implementation fee not published | 6.0 Free plan only Paid plans are contact-sales |
| Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales. | 5.0 No free trial Interactive tour and live demo | 10.0 Free trial Self-serve 30 days, no credit card |
| Contract and lock-inHow we score contract and lock-inMinimum term, whether you can take all your data with you at no extra cost, and other lock-in risks. | 8.0 Annual Export in standard formats; JSON API | 8.0 Annual JSON, PDF and CSV exports; API |
| EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented. | 7.0 Germany available Set per order form; no public QMS DPA | 7.0 EU available AWS US or EU; plan terms not stated; public DPA |
| Budget predictabilityHow we score budget predictabilityHow well you can predict future bills: price-increase clauses, price history and the cost of adding users. | 8.0 Uncapped renewal increases 90 days' notice; no price history before 2026 | 5.0 No cap on renewal increases No paid list prices ever published; no renewal-hike reports found |
| Product | ||
| Compliance coverageHow we score compliance coverageHow much of ISO 13485, FDA and EU MDR the system covers out of the box, based on its documentation. | 8.5 Validation package each release; no UDI or eMDR features found | 6.5 ISO 27001, SOC 2 Type 2; no supplier or audit workflow found |
| Design controls and traceabilityHow we score design controls and traceabilityHow well requirements, risks, tests and software lifecycle are linked, and whether the design history file is generated for you. | 9.0 Linked design, risk and tests; Jira and GitHub sync | 10.0 Generated DHF, trace matrix and risk file from Jira and Git |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 8.0 8.6 / 10 on G2 320 ratings | 5.0 No usable rating 2 reviews on G2 |
| Service | ||
| Support and onboardingHow we score support and onboardingSupport ratings from review sites, plus whether onboarding help is included in the price. | 8.0 9.4 / 10 on G2 308 ratings | 5.0 No usable rating 2 reviews on G2 |
| Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities. | 8.0 4.5/5 on G2 (431 reviews); Reddit split | 5.0 4.8/5 on G2 from 2 reviews; too few to score |
| Time to go liveHow we score time to go liveHow long it usually takes until your team can work in the system, and whether templates are included. | 9.0 2–8 weeks Vendor estimate; SOP templates listed | 6.0 10 weeks–3 months Case studies and a user report |
Scores are out of 10. The better side of each row is highlighted. How we score
| Greenlight Guru | Ketryx | |
|---|---|---|
| Built-in document editor | NoDocuments are files; 2024 tour shows upload and download, editing via Office or Google | YesBuilt-in text editor for EDMS documents |
| Edit in Word or Google Docs | YesCo-edit in Google Docs and Microsoft Office for the web | Partly or add-onGoogle Drive sync; SharePoint publishing in limited rollout; no in-browser Word editing |
| SOP templates included | YesQMS templates listed in the eQMS package; 70+ SOPs and forms | Partly or add-on20 SOP templates; listed on higher plans in 2024–2025 |
| Jira or Git integration | YesJira and GitHub integrations | YesJira, GitHub, GitLab, Bitbucket, Azure DevOps |
| IEC 62304 software features | YesSoftware release management aligned to IEC 62304; SBOM scanning | YesIEC 62304-certified platform, SOUP/SBOM, anomalies, release gates |
| Validation package included | YesIQ protocol plus OQ/PQ reports with every release, included | YesValidation package with every major and minor release |
| Public API | Partly or add-onREST API exists; documentation is for customers only | YesBuild, Project, Item and Group APIs, webhooks |
| Single sign-on (SSO) | YesSSO listed as a platform feature | YesGoogle, GitHub, Okta or any OpenID Connect provider |
| Supplier portal | Partly or add-onSecure sharing with suppliers; no dedicated portal documented | Not confirmed yetNo evidence found |
| Training with quizzes | YesAI drafts training quizzes | Not confirmed yetRead-and-acknowledge training documented; no quizzes found |
| FDA MDR or EU vigilance reporting | Partly or add-onReportability decision and report task; no eMDR submission | Not confirmed yetAdverse-event complaint types, but no documented MDR or vigilance reports |
| AI features | YesGreenlight Guru AI: search, answers, summaries; ISO 42001 | YesAI agents for CAPA drafts, complaint trends and quality review |
| Clause | Requirement | Greenlight Guru | Ketryx |
|---|---|---|---|
| 4.2.4 | Control of documents | ||
| 4.2.5 | Control of records | ||
| 6.2 | Training and competence | ||
| 7.3 | Design and development | ||
| 7.3.9 | Change control | ||
| 7.4 | Supplier qualification and control | ||
| 7.5 | Production records (DMR/DHR) | ||
| UDI | UDI management (EU MDR, FDA) | ||
| 8.2.2 | Complaint handling | ||
| 8.2.3 | Regulatory reporting (FDA MDR, EU vigilance) | ||
| MDR 83 | Post-market surveillance | ||
| 8.2.4 | Internal audit | ||
| 8.3 | Nonconforming product | ||
| 8.5.2 | Corrective action (CAPA) | ||
| ISO 14971 | Risk management file | ||
| IEC 62304 | Software lifecycle | ||
| Part 11 | Electronic signatures |
We haven't written a verdict for this pair yet. The comparison above comes from our research on each system; the full reviews explain each score.