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
- Exclusively focused on the medical device industry.
- Integrated Design Controls and Risk Management modules.
- Strong customer support from medical device professionals.
Unique Value: Provides an end-to-end platform that connects all aspects of the medical device lifecycle, from product development to quality management, specifically for MedTech companies.
🎯 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, every feature is built specifically for medical device workflows and regulations, reducing the need for extensive customization.
💻 Platforms
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (All tier)
🔒 Compliance & Security
💰 Pricing
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