Azora vs Greenlight Guru
Greenlight Guru is the gold-standard QMS for medical device. Azora gives you 80% of the QMS plus PM, ERP, HR, and Finance in one tool, at a fraction of the cost.
Azora
$39
/user/month (Pro)
QMS + everything else. Same database, one login, cross-module reporting.
Trade-off: Newer to the QMS-only market. Greenlight has more out-of-box compliance content (e.g. preloaded ISO 13485 procedures).
Greenlight Guru
$50k+
/year (typical), pricing private
QMS specialist. Deep ISO 13485, FDA, MDR content. Curated compliance consultants. Industry track record.
Trade-off: QMS only. You still need Jira, BambooHR, QuickBooks, Confluence, etc. — and they don't talk to each other.
| Feature | Azora | Greenlight Guru |
|---|---|---|
| QMS Core | ||
| CAPA management | ✓ | ✓ |
| NCR + Change Control | ✓ | ✓ |
| Document control + e-sigs | ✓ | ✓ |
| Risk register (ISO 14971) | ✓ | ✓ |
| Audit management | ✓ | ✓ |
| Training records | ✓ | ✓ |
| Traceability matrix | ✓ | ✓ |
| Preloaded ISO 13485 procedures | Templates | Curated by consultants |
| Beyond QMS | ||
| Project Management (Tasks, Sprint, Gantt) | ✓ | — |
| ERP (Vendors, POs, Units) | ✓ | — |
| HR + Finance + Facilities | ✓ | — |
| Customer support tickets | ✓ | — |
| Wiki / Knowledge base | ✓ | Limited |
| Compliance | ||
| ISO 13485:2016 ready | ✓ | ✓ |
| 21 CFR Part 820 | ✓ | ✓ |
| 21 CFR Part 11 (e-signatures) | ✓ | ✓ |
| EU MDR | Limited | ✓ |
| MDSAP cycle tracker | Q3 2026 | ✓ |
| Operations | ||
| Self-host option | ✓ | — |
| Per-tenant audit log | ✓ | ✓ |
| API access | ✓ | Limited |
| Cost (10-person team, 1 yr) | ||
| Annual cost | $4,680 (Pro) | $50,000+ |
| Tools replaced | 8 | 1 (QMS only) |
| Other tools still needed | 0 | 5+ (PM, HR, ERP, Finance, Wiki) |
When NOT to pick Azora
- You need EU MDR support TODAY (Greenlight has more depth there).
- You want a QMS consultant included in your subscription — Greenlight bundles consulting; we don't.
- Your auditors specifically request a vendor with a published ISO 13485 case study (we'll have these by end-2026).
- You're a Class III implant manufacturer with extensive premarket regulatory needs — Greenlight's content depth wins for now.
Get QMS plus 7 other tools for the price of one Greenlight seat.
Email us and we will provision a seeded tenant for your team within 24 hours — every module unlocked, real sample data, your own login.