Greenlight Guru

Greenlight Guru

Greenlight Guru provides a comprehensive Quality Management System tailored for medical device companies, enhancing compliance and efficiency throughout the MedTech lifecycle.

Location: United States
Software Type: Web App

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Description

Greenlight Guru offers a specialized Quality Management System (QMS) designed for medical device companies, facilitating compliance throughout the MedTech lifecycle. The platform encompasses several functionalities:

- Document Management: Streamlines the creation, approval, and management of documents necessary for regulatory compliance.
- Training Management: Ensures that all personnel are adequately trained and compliant with industry standards.
- Product Development: Manages the entire product life cycle from concept through development to post-market surveillance.
- Risk Management: Assists in identifying, assessing, and mitigating risks associated with medical devices.
- Clinical Data Management: Integrates tools for Electronic Data Capture (EDC), including electronic case report forms to support clinical trials.

This robust platform not only aids in regulatory submissions but also enhances post-market quality management by providing tools to collect and analyze data effectively. Users can benefit from additional resources like webinars, blogs, and customer success stories to navigate the complexities of the MedTech industry.

Greenlight Guru's emphasis on a seamless transition from paper-based systems to a digital framework enhances user experience and ensures regulatory compliance is maintained efficiently.

Features

Document Management

Facilitates the creation, review, and management of essential documents in compliance with regulatory standards.

Training Management

Tracks and manages training programs to ensure all personnel meet industry compliance requirements.

Product Development

Supports the management of the product lifecycle from development through post-market activities.

Risk Management

Provides tools for identifying and mitigating risks throughout the product lifecycle.

Clinical Data Management

Integrates EDC tools for efficient data collection and management during clinical trials.

Tags

Quality ManagementMedical DeviceComplianceSoftwareRegulatoryMedTech

Documentation & Support

  • Installation
  • Documentation
  • Online Support
  • Updates