Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.
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Accelerate product development efforts and improve the quality of regulatory submissions |
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Leverage quality as a strategic advantage to protect your brand and impact the top and bottom lines |
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Grow faster with a quality system that allows you to scale and navigate different international markets |
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Achieve peace of mind knowing your quality system can stay ahead of compliance changes |
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Proactively identify and reduce risk |
With a fully connected QMS that incorporates design controls and risk, your team can assure traceability throughout the product lifecycle in order to expedite device clearance timelines and navigate audits with ease.
Drive collaboration in a centralized workspace for managing device requirements, risk, documents, & quality activities while leveraging Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders.
See how teams are collaborating with Greenlight Guru to accelerate outcomes →
Mitigate the likelihood of missed product development milestones or regulatory delays in achieving device clearance. By taking a proactive approach to managing risk activities over the course of the product lifecycle, your team will be positioned to drive higher quality outcomes for patients and partners.
See how teams are controlling patient and business risk →
With a turn-key medical device quality software platform that offers audit-proven quality templates, built-in controls, medical device expert services, and a modern interface that is easy for teams to learn and use, your team can focus on value added activities that lead to efficient growth.
Learn how innovative teams are scaling quality →
G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.
We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.
The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
Read the Full Review
The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.
Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.
The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.
Easy to upload, organize, and find documents
