CloudPer User/Month
Greenlight Guru
Purpose-built QMS for medical device companies, with strong design control and risk management capabilities.
Medical DevicePharmaceuticals & Biotechnology
Medical device companies requiring FDA 820/ISO 13485 design controls & risk mgmt
Starting: $500/user/month · Implementation: $15,000–$50,000 · Contract: Annual
Visit Greenlight Guru
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Visit Website →Feature Overview
Key capabilities of Greenlight Guru.
Mobile inspections
Offline mode
Real-time SPC
Supplier portal
Training management
Audit management
API access
21 CFR Part 11
AI-powered insights
Compliance Certifications
Platform customizability
Free trial
NC & CAPA Workflows
Tool Calibration & Metrology
Document Control Sign-offs
Shop Floor Integration
Detailed Specifications
Company Profile
- Founded
- 2013
- Employees
- 200+
- Headquarters
- Indianapolis, IN, USA
- Target Size
- Mid-market
Compliance & Validation
- Validation Status
- Validation Ready
- Implementation Speed
- Fast (4–12 weeks)
- Implementation Time
- 10 weeks
- Trial Available
- Demo Only
Pricing Details
- Model
- Per User/Month
- Starting Price
- $500/user/month
- Implementation Fee
- $15,000–$50,000
- Training Included
- Yes
- Contract Term
- Annual
Notable Customers
- Boston Scientific
- Stryker
- Zimmer Biomet
- Hologic
- Insulet
Integrations
JiraSlackMicrosoft TeamsBoxGoogle DriveMinitab
Support & SLA
- SLA
- 2-hour response for critical; dedicated CSM for all accounts
EmailPhoneChatDedicated CsmKnowledge Base
Technical Details
- Mobile App
- Yes
- Offline Capability
- Yes
- Languages
- English
- Data Residency
- US, EU
- Security Certs
- SOC 2 Type II, ISO 27001, HIPAA
- API Docs
- View Documentation
Compliance Matrix
Greenlight Guru alignment with key regulatory standards.
| Standard / Regulation | Supported |
|---|---|
| ISO9001 | |
| ISO13485 | |
| ISO14971 | |
| FDA21CFR820 | |
| FDA21CFR11 | |
| MDSAP | |
| EUMDR | |
| IATF16949 | |
| AS9100 |
Certifications
ISO 13485ISO 14971FDA 21 CFR 820FDA 21 CFR Part 11MDSAPEU MDR
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