(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.

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