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Quality and clinical software purpose-built for medical devices
Greenlight Guru is a quality management platform offering a QMS and clinical platform purpose-built for medical device companies and design controls. Founded in 2013 and based in Indianapolis, Indiana, USA, Greenlight Guru helps medical device startups and manufacturers manage compliance, reduce risk and stay audit-ready across sites.
Greenlight Guru is built for medical device startups and manufacturers. It suits organizations that need design control and risk (ISO 14971) and want quality and safety processes standardized rather than run on spreadsheets.
Compared with alternatives like MasterControl, Greenlight Guru differentiates on design control and risk (ISO 14971). Pricing is quote-based and scoped to your modules, users and sites, so it fits established quality management programs.
Pricing Model
Quote-based
Starting Price
Contact vendor
Free Options
Free trial
Core Greenlight Guru for a single site or team. Contact for a quote.
Advanced Greenlight Guru for multi-site, regulated programs. Contact for a quote.
| Feature | Professional Popular | Enterprise |
|---|---|---|
| design control and risk (ISO 14971) | , | |
| document control and CAPA | , | |
| audit and complaint management | , | |
| Audit trails and reporting | , | |
| Standard integrations | , | |
| Everything in Professional | , | |
| clinical data capture (EDC) | , | |
| Validation support and e-signatures | , | |
| SSO and enterprise security | , | |
| Dedicated support and onboarding | , |
Other
CRM
HR & People
Authentication
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API Types
SDK Availability
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Developer Features
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Compliance Standards
SOC 2 Type II
EnterpriseISO 27001
EnterpriseGDPR Compliant
GlobalHIPAA
HealthcarePCI DSS
FinanceCCPA
PrivacyFedRAMP
GovernmentCSA STAR
CloudDeployment & Data
Data Residency Options
Verify with vendor for your specific region requirements.
Cloud HSEQ platform for safety, compliance and workflows (HSI Donesafe)
Quality management and regulatory compliance platform
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