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greenlight.guru

FDA Compliance

Greenlight Guru Announces New Integration With Jira Software

Creates adaptive system for managing product development and post-market quality for devices with software elements

Published: Tuesday, November 20, 2018 - 14:40

(Greenlight Guru: Indianapolis) -- Greenlight Guru, the only 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.

Medical device design controls have historically been a top observation cited by the U.S. Food and Drug Administration (FDA) during inspections, with many medical device companies struggling to demonstrate robust design controls via traditional spreadsheets or disconnected sets of documentation. With the growth of Software as a Medical Device (SaMD) applications, along with the proliferation of hardware-based devices now incorporating software or firmware elements, managing and maintaining design control traceability has become increasingly complex.

“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 vice president 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 Management software release and a recent partnership with the FDA that has provided meaningful insight into the FDA’s Case for Quality initiative.

For more information about Greenlight Guru’s new Jira integration, visit www.greenlight.guru/design-control-software.

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greenlight.guru

greenlight.guru offers consulting services and comprehensive, integrated, wholly traceable, quality management system software for medical device companies to get devices to market faster while ensuring compliance.