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 →
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G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.
With Greenlight Guru, I can follow all the steps of our quality management system and make sure all regulatory requirements are met. The most significant benefit for me is being able to accurately verify that all risks are managed and that all design checks are carried out. The software allows us an extremely rigorous follow-up which is and will be a big help for us.
We are solving document control and design controls with the Greenlight Guru Software. It is easier to release documents and gather signatures for controlled documents. The design controls system has made project management more manageable by having all the documents in one place.
The Greenlight Guru customer success team has helped us navigate the entire process so far, with no ask too large and no question left unanswered. It has by far been one of the best customer service experiences I've had to date.
Having come from one of the largest medical device companies globally to a start-up with no QMS, yet alone, an eQMS, the transition to Greenlight has saved my team countless hours and provided an ability, especially during COVID, to do remote approvals of documents, assign tasks, and give visibility to the appropriate team members of a variety of modules in order to collaborate and move forward with pre- and post-market activities.
#1 - Customer Service! Our Customer Success Manager and Medical Device Guru are both incredibly patient and responsive anytime that my team and I email them questions. They are also genuinely appreciate unfiltered feedback from their customers. Their positive attitudes and attentiveness, specifically throughout our onboarding process, has been instrumental to our success in implementing GG. We did NOT feel like we were left on our own during this process.
The biggest gain for us has been being able to get our QMS up and running from scratch in less than 3 months. It is reassuring knowing that the system helps us to be ISO 13485 and 14971 compliant. We have found GG to be very useful in documenting our design controls and risk matrix. We really like how the system allows you to connect these areas.
