Greenlight Guru

A quality control software designed for the medical device industry, providing tools for product development, risk management, and regulatory compliance.

Product Overview

Greenlight Guru is a cloud-based quality management software tailored for the medical device industry. It excels in managing both premarket and post-market phases, offering features like risk management, design control, and audit management. It maintains traceability in design control and automates document routing and revision control.


  • Responsive customer support
  • Intuitive, user-friendly interface
  • Automated document routing and revision control


  • Tedious mass document input
  • Detailed, specialized modules can pose a learning curve

Target Market

Small companies with 10-50 employees and mid-sized businesses with 50-1,000 employees in the medical device industry.

About Greenlight Guru

Greenlight Guru is a quality management platform designed for the medical device industry, assisting in faster market entry of safer products and easing compliance with FDA and ISO regulations. It streamlines document control and design traceability, vital for meeting stringent regulatory requirements in the medical device field.

The software effectively integrates design control with risk management. It offers tools for managing standard operating procedures (SOPs), policies, and work instructions. It also assists in managing supplier-related processes and ensures that suppliers meet required quality standards.

Greenlight Guru Features

  • Design Control: Streamlines the process of managing product designs, ensuring compliance with industry standards.
  • Risk Management: Provides tools for identifying and mitigating risks throughout product development.
  • Document Management: Facilitates efficient organization and control of critical documentation.
  • Change Management: Manages changes in processes or products, ensuring traceability and compliance.
  • Training Management: Organizes and tracks employee training, essential for regulatory compliance.
  • Audit Management: Supports the conducting and management of internal and external audits.
  • Complaint Management: Enables systematic handling of customer complaints, vital for quality control.
  • Nonconformance Management: Identifies, documents, and addresses instances of nonconformance to standards.
  • CAPA Management (Corrective and Preventive Actions): Addresses and prevents issues in processes or products.
  • Analytics & Reporting: Offers insights through data analysis and comprehensive reporting capabilities.

Greenlight Guru Target Market

  • Medical Device Enterprises: Particularly effective for small to mid-sized businesses involved in manufacturing, designing, and developing medical devices.
  • Key Departments: Primarily used by departments focusing on Quality Control, Regulatory Affairs, and Product Development.
  • Executive Utilization: Executives in these sectors also find significant value in the platform for overseeing and managing compliance and quality processes.

Greenlight Guru Pricing

The cost of Greenlight Guru starts at $600/user/month. The pricing model is packages priced per user. There is no free trial available. There is no free version available.

Starting Price
$600 /user/month
Price Range Learn More
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Product Overview

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