Greenlight Guru
The MedTech Lifecycle Excellence Platform.
Overview
Greenlight Guru provides a Quality Management Software (QMS) specifically designed for the medical device industry. It helps companies manage design controls, risk management, document control, and other quality processes to ensure compliance with regulations like FDA 21 CFR Part 820 and ISO 13485. The platform aims to streamline product development and accelerate market entry for MedTech companies.
✨ Key Features
- Design Controls
- Risk Management (ISO 14971)
- Document Management
- CAPA Management
- Change Management
- Audit Management
- Training Management
- Supplier Management
- Nonconformance Management
🎯 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 (5)
✅ Best For
- Managing design controls and risk for medical device development.
- Streamlining document review and approval processes.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Companies outside the medical device industry.
- Organizations not requiring compliance with ISO 13485 or FDA regulations.
🏆 Alternatives
Unlike general-purpose QMS, every feature is built specifically for medical device workflows and regulations, reducing the need for extensive customization.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (All tier)
🔒 Compliance & Security
💰 Pricing
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