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Greenlight Guru

greenlight.guru

From $750/mo WebAPI

Spec sheet

Purpose
Greenlight Guru provides quality management, product development, and clinical evidence software designed for medical device companies.Read 9 Oct 2026 · greenlight.guru
Deployment
Greenlight Guru is cloud-based, accessed through a web browser, runs on Amazon Web Services, and requires no customer hosting.Read 9 Oct 2026 · greenlight.guru
Integrations
Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web; the REST API supports custom connections.Read 9 Oct 2026 · greenlight.guru
Security
Greenlight Guru says it is certified to ISO 27001, ISO 42001, ISO 9001, and SOC 2, and that subscriptions include role-based security and encryption.Read 9 Oct 2026 · greenlight.guru
Support
Subscriptions include a dedicated customer success manager, training resources, and support; implementation is quoted separately.Read 9 Oct 2026 · greenlight.guru
Headquarters
Indianapolis, Indiana, United StatesRead 28 Sep 2026 · greenlight.guru
AI privacy
The company states that customer data is not used to train AI models and that its AI management system is certified to ISO 42001.Read 9 Oct 2026 · greenlight.guru
Clinical EDC
The Clinical product captures compliant clinical data and supports studies, adverse event tracking, randomization, and multi-language forms.Read 9 Oct 2026 · greenlight.guru
Company history
The company says the initial idea for Greenlight Guru arose in 2006 and names Jon Speer and co-founder David DeRam as its developers.Read 9 Oct 2026 · greenlight.guru
Data portability
Customers can export quality records and clinical study data in standard formats without buying a separate services engagement.Read 9 Oct 2026 · greenlight.guru
Design controls
The product supports requirements, reviews, verification, validation, design history files, and links between risk controls and requirements.Read 9 Oct 2026 · greenlight.guru
Implementation
Most standard eQMS implementation engagements take two to eight weeks, depending on scope.Read 9 Oct 2026 · greenlight.guru
Integration limit
Most pre-built integrations run on a schedule or trigger rather than continuous real-time sync, and customers build and maintain their own API connections.Read 9 Oct 2026 · greenlight.guru
Quality management
Its eQMS connects design, risk, documents, training, suppliers, and quality events and is described as aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304.Read 9 Oct 2026 · greenlight.guru

Plans and prices

Greenlight Guru Clinical Essentials $9,000 a year EDC subscriptions start at $9,000 per year; 12-month minimum, with an option to contract for the full study length. Up to 1 ongoing study · Up to 10 sites · 100GB file vault · eConsent and custom reports/notifications are add-ons Read 9 Oct 2026 · greenlight.guru
Greenlight Guru eQMS $12,000 a year Packages start at $12,000 per year; subscription is annual. Price depends on products and capabilities; implementation priced separately Read 9 Oct 2026 · greenlight.guru
Greenlight Guru Clinical Plus Priced on request Contact Greenlight Guru for pricing; EDC subscriptions have a 12-month minimum. Everything in Essentials · Up to 3 ongoing studies · Up to 30 sites Read 9 Oct 2026 · greenlight.guru
Greenlight Guru Clinical Professional Priced on request Contact Greenlight Guru for pricing; EDC subscriptions have a 12-month minimum. Everything in Essentials and Plus · Up to 5 ongoing studies · Up to 50 sites · eConsent Read 9 Oct 2026 · greenlight.guru

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