Greenlight Guru

What Greenlight Guru is

Greenlight Guru provides quality management, product development, and clinical evidence software for medical device companies. Its cloud-based eQMS connects design, risk, documents, training, suppliers, and quality events, and is described as aligned with ISO 13485, FDA QMSR, ISO 14971, and IEC 62304. Design controls cover requirements, reviews, verification, validation, design history files, and links between risk controls and requirements. The Clinical product captures compliant study data and supports adverse event tracking, randomization, and multi-language forms. Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web, while a REST API allows custom connections. 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. The browser-based service runs on Amazon Web Services and requires no customer hosting. Subscriptions include role-based security, encryption, a dedicated customer success manager, training resources, and support. The company says it is certified to ISO 27001, ISO 42001, ISO 9001, and SOC 2, and that customer data is not used to train AI models. Pricing is on request; listed annual starting prices are 9000.00 USD for Clinical Essentials and 12000.00 USD for eQMS. Implementation is quoted separately.