Looking for a Greenlight Guru Alternative?
Greenlight Guru is a QMS. regMD is regulatory intelligence. Different tools, complementary purposes — but if you need classification and regulatory alerts, not document management, regMD is what you're looking for.
What is Greenlight Guru?
Greenlight Guru is the leading cloud-based eQMS built specifically for medical device companies. It manages design controls, CAPAs, document management, risk management, and quality processes for FDA 21 CFR Part 820 and ISO 13485 compliance.
Pricing
Starting at ~$600/user/month. Minimum 5 users for most plans. Annual contracts. Total cost: $36,000–$100,000+/year.
What is regMD?
regMD is a regulatory intelligence platform for medical devices. Classify your device across 15 jurisdictions, track your portfolio, get AI-powered regulatory alerts, plan expansion pathways, and manage compliance obligations — all for a one-time $99 lifetime access fee.
Pricing
$99 one-time payment — lifetime access to all features
Feature Comparison
| Feature | Greenlight Guru | regMD |
|---|---|---|
| Device classification | Not a feature | Core feature (15 jurisdictions) |
| Regulatory alerts | Not a feature | AI-powered, personalized |
| Pathway guidance | Not a feature | Yes (with What-If simulator) |
| Document management | Core feature | Not included |
| Design controls | Core feature | Not included |
| CAPA management | Core feature | Not included |
| Risk management | Yes (ISO 14971) | Not included |
| Compliance tracking | QMS compliance | Regulatory obligations |
| Pricing | $600/user/mo | $99 lifetime |
| Multi-jurisdiction intelligence | No | 15 jurisdictions |
Greenlight Guru Limitations
- It's a QMS, not regulatory intelligence — no classification or alerts
- $600/user/month is prohibitive for early-stage companies
- Doesn't help you figure out WHICH markets to enter or HOW
- No multi-jurisdiction classification or pathway guidance
- Minimum user requirements lock out solo consultants
regMD Advantages
- Regulatory intelligence, not document management
- Instant multi-jurisdiction classification across 15 markets
- AI-powered regulatory change alerts personalized to your devices
- $99 lifetime — not $600/user/month
- Pathway finder with What-If expansion simulator