Greenlight Guru
The only MedTech Lifecycle Excellence Platform.
Overview
Greenlight Guru provides a QMS platform specifically designed for medical device companies to help them achieve compliance with standards like FDA 21 CFR Part 820 and ISO 13485. It includes modules for document management, design controls, risk management, and CAPA, with pre-validated workflows.
✨ Key Features
- Design Controls
- Risk Management
- Document Management
- CAPA Management
- Training Management
- Change Management
- AI-powered Risk Intelligence
🎯 Key Differentiators
- Exclusive focus on the medical device industry.
- Integrated design controls and risk management.
- In-house team of medical device experts for customer support.
Unique Value: Provides a purpose-built platform with deep domain expertise to help medical device companies accelerate product development and simplify regulatory compliance.
🎯 Use Cases (3)
✅ Best For
- Purpose-built for medical device companies and compliant with FDA and ISO 13485 standards.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Less focused on the specific batch record and manufacturing needs of 503B pharmacies compared to other QMS.
🏆 Alternatives
Unlike general-purpose QMS, Greenlight Guru is pre-configured for medical device regulations, reducing the time and effort needed for implementation and validation.
💻 Platforms
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (All tier)
🔒 Compliance & Security
💰 Pricing
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