Greenlight Guru

Greenlight Guru provides cloud-based quality management software for the medical device industry. The platform helps medical device manufacturers speed up product development and streamline regulatory compliance processes. The company claims its solution has saved USD 125,000 in average per project and brought products to market three months faster (August 2024).

Greenlight Guru's main product is an electronic Quality Management System (eQMS) that supports compliance with FDA, ISO, and EU regulations. It centralizes key quality-related processes, such as document control, CAPA management, supplier oversight, and risk management, offering real-time visibility and collaboration. This system helps companies manage quality processes more efficiently through a unified platform.

The company has also expanded its offerings to include clinical data management and product development. The Clinical Solutions platform improves the management of clinical trials with intelligent workflows. At the same time, the Greenlight Guru Products module enables teams to manage bills of materials, product families, and engineering changes with full traceability throughout the product lifecycle.

In January 2022, it acquired CanvasGT, a software company that enables collaboration and design history capture during the early stages of medical device development. 

Key customers and partnerships

Greenlight Guru provides quality management software for the medical device industry. As of July 2024, over 1,100 medical device companies were using its solution. Notable customers include Sonavex, Parker, Astrego Diagnostics, and SurgEase Innovations. 

The company had established several partnerships to further enhance its offerings. In October 2018, Greenlight Guru integrated with Jira Software, allowing software development teams to use Jira's agile features. In December 2023, Greenlight Guru partnered with HTEC Group to enhance its quality management platform. This collaboration aimed to create a scalable, resilient, and modular architecture, enabling faster regulatory compliance and quicker product rollouts for Greenlight Guru's customers.