Greenlight Guru

Overview

Greenlight Guru is a software company based in the United States, established in 2013, that specializes in providing solutions for the medical device industry. With a workforce of 201 to 500 employees, the company focuses on business intelligence software and management consulting services tailored to meet the regulatory requirements of medical device quality management systems (QMS). Their published materials include a comprehensive guide on ISO 13485 and FDA Quality System Regulations (QSR), which outlines the essential steps for implementing a QMS. The guide addresses various aspects such as risk management, document control, training management, and compliance with international standards. It emphasizes the importance of documentation in the medical device sector, highlighting that proper records management is critical for regulatory compliance. Greenlight Guru's expertise lies in helping organizations streamline their QMS processes, ensuring that they meet necessary regulatory standards while facilitating product development and market readiness.

Industry