Greenlight Guru Announces New Integration with Jira Software

Quality management software platform for medical device companies now integrates with issue and project tracking tool.

Quality management software platform for medical device companies now integrates with issue and project tracking tool.

Greenlight Guru, quality management software platform designed specifically for medical device companies, announces a new integration with Jira, creating an adaptive system for managing product development and post-market quality for devices with software elements. 

“Modern medical devices contain hardware, software and firmware levels, each of which is commonly owned and developed by cross-functional teams,” says Jon Speer, Greenlight Guru co-founder and VP of Quality Assurance and Regulatory Affairs. “This integration allows product managers to track and maintain compliance mandated by regulatory bodies while enabling software development in one of the most popular and adaptable management environments in the industry.” 

The new integration allows medical device companies to reduce the risk of noncompliance by ensuring the appropriate Jira artifacts are captured in their quality management system. Software development teams have the freedom to leverage the agile functionality of Jira for tracking implementation work and issues related to software components, while simultaneously ensuring traceability to their Design Control and Risk Management system of record within Greenlight Guru. 

“The agile development approach has helped bring about world-class technology like Gmail, Spotify and Salesforce,” says Greenlight Guru co-founder and CEO David DeRam. “Greenlight Guru and Jira are the industry leaders in their respective fields; and, this new partnership will help usher in the next generation of quality-focused medical devices to market.” 

This announcement follows Greenlight Guru’s Advanced Document Managementsoftware release and a recent partnership with the FDA that has provided insight into the FDA’s Case for Quality initiative. 

Greenlight Guru is a quality management software platform designed specifically for medical devices companies. This platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes, such as CAPAs, risk management, design control and more. Greenlight Guru’s software solution is used by users across the globe, allowing teams to push beyond baseline compliance and achieve True Quality for their devices and the patients who use them.

Sources: Press materials received from the company.


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