CompareArena QMS vs Greenlight Guru
est. $12–25k/yr
Vendr: QMS $1,200–2,500 per user a year; implementation extra
Choose it if: You build physical medical devices with outsourced manufacturing and want CAPA, complaints, training and design records linked to the same BOM and change orders as your engineering data.
Watch out: Pricing is quote-only with paid implementation and validation add-ons, and there are no risk-management, IEC 62304 or regulatory-reporting features.
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.
| Arena QMS 6.6 | Greenlight Guru 7.4 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 7.0 est. $12–25k/yr Vendr: QMS $1,200–2,500 per user a year; implementation extra | 5.5 from $12k/yr Buyers report $21–55k a year (Vendr) |
| Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website. | 3.0 Contact sales only Prices published until 2016; services and validation unpriced | 5.0 Starting price only Implementation fee not published |
| Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales. | 7.0 Free trial 10-day trial by request form, no credit card; live demo | 5.0 No free trial Interactive tour and live demo |
| 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. | 5.0 Annual CSV data export during the term; post-exit export is charged as professional services | 8.0 Annual Export in standard formats; JSON API |
| EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented. | 10.0 EU (AWS) available Public PTC DPA and sub-processor list | 7.0 Germany available Set per order form; no public QMS DPA |
| Budget predictabilityHow we score budget predictabilityHow well you can predict future bills: price-increase clauses, price history and the cost of adding users. | 5.0 No cap on renewal increases 30 days' notice of any increase; per-user licences; no list price since 2016 | 8.0 Uncapped renewal increases 90 days' notice; no price history before 2026 |
| 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. | 8.0 SOC 2 Type 2; Arena Validate (IQ/OQ/PQ) is an add-on; no UDI or vigilance features | 8.5 Validation package each release; no UDI or eMDR features 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. | 5.5 Requirements trace links and DHF via Projects; no risk or IEC 62304 tools | 9.0 Linked design, risk and tests; Jira and GitHub sync |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 8.0 8.1 / 10 on G2 420 ratings | 8.0 8.6 / 10 on G2 320 ratings |
| Service | ||
| Support and onboardingHow we score support and onboardingSupport ratings from review sites, plus whether onboarding help is included in the price. | 8.0 8.5 / 10 on G2 347 ratings | 8.0 9.4 / 10 on G2 308 ratings |
| Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities. | 8.0 4.2/5 on G2 (465 reviews, PLM and QMS combined) | 8.0 4.5/5 on G2 (431 reviews); Reddit split |
| 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. | 5.0 Unknown No QMS rollout quantified; PLM rollouts took 3–8 weeks | 9.0 2–8 weeks Vendor estimate; SOP templates listed |
Scores are out of 10. The better side of each row is highlighted. How we score
| Arena QMS | Greenlight Guru | |
|---|---|---|
| Built-in document editor | NoDocuments are files; editing runs through a paid Microsoft 365 or Google Docs connection | NoDocuments are files; 2024 tour shows upload and download, editing via Office or Google |
| Edit in Word or Google Docs | YesCloud Documents Connection for Microsoft 365 or Google Docs (extra cost on the QMS plan) | YesCo-edit in Google Docs and Microsoft Office for the web |
| SOP templates included | Partly or add-onConfigurable quality process templates; no SOP template library found | YesQMS templates listed in the eQMS package; 70+ SOPs and forms |
| Jira or Git integration | YesJira and GitHub connectors in Arena Connect (3 workflows on the QMS plan) | YesJira and GitHub integrations |
| IEC 62304 software features | Not confirmed yetNo IEC 62304 features found | YesSoftware release management aligned to IEC 62304; SBOM scanning |
| Validation package included | Partly or add-onArena Validate with URS, IQ/OQ and PQ templates, sold as an add-on | YesIQ protocol plus OQ/PQ reports with every release, included |
| Public API | YesPublic REST API with an OpenAPI spec and Swagger UI | Partly or add-onREST API exists; documentation is for customers only |
| Single sign-on (SSO) | YesSAML SSO included in the QMS plan | YesSSO listed as a platform feature |
| Supplier portal | YesSupplier licences give partners role-based access to the product record | Partly or add-onSecure sharing with suppliers; no dedicated portal documented |
| Training with quizzes | YesTraining plans with quizzes and Part 11 read-and-understood sign-off | YesAI drafts training quizzes |
| FDA MDR or EU vigilance reporting | Partly or add-onSerious-incident report templates named in a white paper; no eMDR or EUDAMED submission | Partly or add-onReportability decision and report task; no eMDR submission |
| AI features | YesArena AI search, file summaries and comparisons; LLM features are opt-in | YesGreenlight Guru AI: search, answers, summaries; ISO 42001 |
| Clause | Requirement | Arena QMS | Greenlight Guru |
|---|---|---|---|
| 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.