What is Greenlight Guru?
Greenlight Guru offers comprehensive software solutions tailored for medical device companies throughout the entire product lifecycle. The platform combines artificial intelligence with deep industry expertise to help organizations manage quality events, documentation, training, and clinical data in a unified system. Built specifically for medical device regulatory requirements, it enables teams to maintain audit-ready records while accelerating product development and ensuring compliance with standards like ISO 13485, ISO 14971, and 21 CFR Part 820.
The platform features AI-powered traceability and predictive verification checks that help identify issues faster and make smarter decisions with reduced manual work. It connects design controls, risk management, and verification processes while providing automated routing, audit trails, and role-based access controls. Greenlight Guru supports both pre-market and post-market activities, including clinical trial data collection through validated electronic data capture systems for medical device studies.
Features
- AI-Powered Traceability: Connect design inputs, outputs, verifications, and risk controls with predictive verification checks
- Comprehensive Quality Management: Track CAPAs, audits, nonconformances, and quality events with audit-ready records
- Document Control System: Manage documents, changes, and training with automated routing and role-based access
- Clinical Data Collection: Capture compliant clinical data across all study phases with validated electronic data capture
- Risk Management Tools: Assess ISO 14971 risk as requirements and tests evolve throughout development
Use Cases
- Managing quality management systems for medical device compliance
- Tracking design controls and design history files throughout product development
- Collecting clinical trial data for medical device studies
- Managing post-market quality events and surveillance activities
- Preparing for regulatory submissions and audits
- Qualifying suppliers and managing supply chain operations
- Implementing risk management according to ISO 14971 requirements
- Migrating from paper-based quality systems to digital platforms
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Greenlight Guru Uptime Monitor
Average Uptime
100%
Average Response Time
146.13 ms
