CompareFormwork vs Greenlight Guru
$7k/yr
499 € a month flat for unlimited users; 99 € for up to 5
Choose it if: You're an early-stage device startup, especially one building software, and want a cheap, self-serve QMS with templates and linked requirements, risks and tests.
Watch out: We found no complaint handling, internal audit planning, vigilance reporting or UDI features, and change control is barely documented.
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.
| Formwork 7.6 | Greenlight Guru 7.4 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 8.5 $7k/yr 499 € a month flat for unlimited users; 99 € for up to 5 | 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. | 10.0 Full price list All three tiers and their limits published | 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. | 10.0 Free tier Self-serve sign-up, no sales call | 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. | 7.0 Annual Terms say yearly auto-renewal; marketing says monthly | 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. | 8.0 France (backups in Germany) DPA generated in the app; no public subprocessor 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. | 8.0 No cap on renewal increases Main tier fell from 799 € to 499 € in 2025; flat price for any team size | 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. | 5.0 CAPA, supplier and training documented; validation report; no ISO 27001 or SOC 2 found | 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. | 9.0 Linked requirements, tests and risks with spreadsheet exports; no Jira or Git | 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. | 5.0 | 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. | 6.0 | 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. | 5.0 2 reviews on G2, 0 on Capterra (Sep 2026) | 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. | 10.0 Days to 2 weeks Vendor estimate; templates included | 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
| Formwork | Greenlight Guru | |
|---|---|---|
| Built-in document editor | YesRich-text editor with tables and images, stored as Markdown | NoDocuments are files; 2024 tour shows upload and download, editing via Office or Google |
| Edit in Word or Google Docs | Not confirmed yetWord files can be uploaded but not edited in place; no documented Office or Google Docs editing | YesCo-edit in Google Docs and Microsoft Office for the web |
| SOP templates included | YesOpenRegulatory's free QMS and technical documentation templates built in | YesQMS templates listed in the eQMS package; 70+ SOPs and forms |
| Jira or Git integration | NoVendor says there's no Jira or development-tool integration, by design | YesJira and GitHub integrations |
| IEC 62304 software features | YesSafety class per product, requirement categories, detailed design for class C, tests and test runs | YesSoftware release management aligned to IEC 62304; SBOM scanning |
| Validation package included | YesPre-filled validation report with screenshots of each tested requirement, generated in the app | YesIQ protocol plus OQ/PQ reports with every release, included |
| Public API | Partly or add-onNo REST API docs found; the manual lists MCP access with machine tokens | Partly or add-onREST API exists; documentation is for customers only |
| Single sign-on (SSO) | Partly or add-onGoogle sign-in; no SAML SSO found | YesSSO listed as a platform feature |
| Supplier portal | Not confirmed yetSupplier list for your own evaluations; no supplier access found | Partly or add-onSecure sharing with suppliers; no dedicated portal documented |
| Training with quizzes | YesTraining effectiveness by quiz or a named person (paid plans) | YesAI drafts training quizzes |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting feature found | Partly or add-onReportability decision and report task; no eMDR submission |
| AI features | YesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generate | YesGreenlight Guru AI: search, answers, summaries; ISO 42001 |
| Clause | Requirement | Formwork | 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.