Greenlight Guru
VerifiedPurpose-built eQMS and clinical data platform for medical device companies.
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See all screenshots - Deployment Cloud Based
- Starting price Custom
- Free trial Not offered
- Best for Startups, SMEs, Enterprises
What is Greenlight Guru?
Greenlight Guru is a purpose-built electronic quality management system for medical device companies, aligned to FDA QSR/QMSR, ISO 13485, ISO 14971, and EU MDR. Its connected modules cover document management, change management, CAPA and nonconformance, audit management, supplier management, training, and design controls with built-in traceability across the design history file, plus a separate clinical data capture tool for MedTech trials.
Pricing is organized around a Core package (document, training, and change management) with optional Product Development and Quality Events add-ons for design controls and CAPA/audit functionality. Greenlight Guru does not publish prices online, offers no free trial or free plan, and requires all new customers to purchase one-time onboarding services before go-live.
Key Features of Greenlight Guru
Greenlight Guru lists 10 documented features, including Document management, Change management and CAPA and nonconformance management. The list below covers what the product does rather than how it is marketed.
- Document management
- Change management
- CAPA and nonconformance management
- Audit management
- Supplier management
- Training management
- Design controls with DHF traceability
- AI-powered design verification suggestions
- Clinical data capture for MedTech trials
- Risk management aligned to ISO 14971
Greenlight Guru Pricing
Greenlight Guru lists 4 plans without published figures. Pricing is quoted on request.
Core
Custom
10 users, 300 documents, 10 training requirements included
Foundation package with document management, training management, change management, SSO, and data exports.
Product Development (add-on)
Custom
Adds design controls, risk management, and product management capabilities.
Quality Events (add-on)
Custom
Adds CAPA, audit, nonconformance, and customer feedback functionality.
Guru Services (add-on)
Custom
Optional on-demand assistance and dedicated expert support.
Greenlight Guru Specifications
Greenlight Guru is available on web app. It offers an API.
- Deployment
- Cloud Based
- Billing cycle
- Yearly
- Desktop
- Web App
- Languages
- English
- Built for
- Startups
- SMEs
- Enterprises
- Support
- Live Support
- Training
- Tickets
- Integrations
- Single sign-on, data export tools, and third-party design/PLM systems
- Public API
- Yes
- Free trial
- No
- Free plan
- No
- Runs in browser
- Yes
- Customisable
- Yes
- Website
- greenlight.guru
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