Greenlight Guru recently announced that it has integrated with Jira Software to create an adaptive system for managing product development and postmarked quality for devices that have software elements.
The FDA is starting to look at medical device design controls during inspections as medical device companies start to demonstrate their controls through traditional spreadsheets or disconnected sets of documentation, according to Greelight Guru. As software as a medical device continues to grown, managing and maintaining design control traceability is becoming more complex.
“Modern medical devices contain hardware, software and firmware levels, each of which is commonly owned and developed by cross-functional teams,” Jon Speer, co-founder and VP of quality assurance and regulatory affairs at Greenlight Guru, said. “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 integration of Jira Software helps medical device companies reduce noncompliance risks by ensuring the appropriate artifacts are captured in their quality management system. Jira can help software development teams track implementation work and issues that happen with software components while also ensuring traceability to design control and risk management systems of record at Greenlight Guru.
“The agile development approach has helped bring about world-class technology like Gmail, Spotify and Salesforce,” David DeRam, co-founder and CEO of Greenlight Guru, said. “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.”
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