INDIANAPOLIS — Greenlight Guru announced the addition of Grow to its existing quality management software platform, aimed to help companies get high-quality medical devices to market faster and with less risk.

Now, with the introduction of their Grow product, Greenlight Guru’s software can assist medical device companies after the launch of a device by connecting its entire quality ecosystem and advancing the success of high-quality devices already on the market.

According to the FDA, Corrective and Preventive Actions (CAPA) continue to be the number one reason medical device companies are cited for 483 Observations. The reason is because many medical device companies are still using a paper-based system to connect the disparate processes, sources, people and data within a quality system. Or, the companies are opting for an eQMS that isn’t tailored toward the medical device industry and doesn’t address the changing FDA regulations and ISO standards in which the medical device industry must adhere.

“After experiencing this pain firsthand working in product development and management for medical device companies, I knew there needed to be an easier way to help companies not only get to market faster but improve their post-market quality processes beyond just compliance,” said Jon Speer, founder and VP of QA/RA at Greenlight Guru. “Grow has additional workflows for CAPA and other post-market needs that will help these companies who are flying blind without visibility into their quality system and are subject to unnecessary risk."

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