New Software Connects Device Companies’ Entire Quality “Ecosystem”

New software, dedicated to the medical device industry, promises to harness Corrective and Preventive Actions (CAPA)


Greenlight Guru’s claim to fame is that it is the only quality management platform designed specifically for medical devices companies. The result, says the company, gets 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 like CAPAs, risk, audits and more.

With its “Go” package, Greenlight Guru’s first product, companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time.

According to the FDA, 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.

NowGreenlight Guru has added so-called “Grow” to its existing quality management software platform. The new software can assist companies after the launch of a medical device by connecting its entire quality ecosystem and advancing the success of high-quality devices already on the market. Specifically Grow delivers the ability to effectively manage risk-based CAPA process in a connected ecosystem where inputs and outputs tell the true story.

Company comments

“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 postmarket 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 postmarket needs that will help these companies who are flying blind without visibility into their quality system and are subject to unnecessary risk.”

Customer comments

“The new Greenlight Guru Grow product will be very helpful in our ability to escalate and manage quality events that require a CAPA investigation,” said Eric Rock, customer and QA/RA Manager, Litecure. “Being able to easily link and connect nonconformances, complaints, audit findings, CAPAs and documents will greatly improve our internal efficiency and compliance and allow us to put our focus squarely on the quality of our products.”

Source: PR Web

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